Applicator and tissue interface module for dermatological device

ABSTRACT

A tissue interface module has an applicator chamber on a proximal side of the tissue interface module and a tissue acquisition chamber on a distal side of the tissue interface module. The applicator chamber may include: an opening adapted to receive the applicator; an attachment mechanism positioned in the applicator chamber and adapted to attach the tissue interface module to the applicator; a sealing member positioned at a proximal side of the applicator chamber; and a vacuum interface positioned at a proximal side of the applicator chamber and adapted to receive a vacuum inlet positioned on a distal end of the applicator. The invention also includes corresponding methods.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/090,273, filed Apr. 4, 2016, now U.S. Pat. No. 10,321,954, which is adivision of U.S. application Ser. No. 13/563,656, filed Jul. 31, 2012,now U.S. Pat. No. 9,314,301, which claims the benefit under 35 U.S.C. §119 of U.S. Provisional Patent Application No. 61/513,834, filed Aug. 1,2011, titled “Applicator and Consumable for Dermatological Device”; U.S.Provisional Patent Application No. 61/555,410, filed Nov. 3, 2011,titled “Applicator and Tissue Interface Module for DermatologicalDevice”; U.S. Provisional Patent Application No. 61/673,697, filed Jul.19, 2012, titled “Applicator and Tissue Interface Module forDermatological Device”; and U.S. Provisional Patent Application No.61/676,833, filed Jul. 27, 2012, titled “Applicator And Tissue InterfaceModule For Dermatological Device,” the disclosures of which areincorporated herein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

This disclosure relates generally to application of energy to tissue.More specifically, this disclosure relates to application of energy totissue to treat conditions of the skin, epidermis, dermis andhypodermis.

BACKGROUND

Hyperhidrosis or excessive sweating is a common disorder which canresult in excessive underarm, facial, or foot sweating. Excessivesweating may cause physical side-effects, including dehydration andinfections, as well as emotional side-effects such as embarrassment.Many forms of treatment of hyperhidrosis are currently known, includingmedications, antiperspirants, botulinum toxins, and ablation therapy.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 illustrates a physician holding an applicator and a patientpositioned to receive treatment.

FIG. 2 shows a perspective view of a tissue interface module attached toan applicator.

FIG. 3 illustrates a perspective view of a tissue interface moduledetached from an applicator.

FIG. 4 shows an end view of a multifunction connector.

FIG. 5 illustrates an end view of a tissue interface module.

FIG. 6 is a top view of a tissue interface module.

FIG. 7 shows a top perspective view of a tissue interface module.

FIG. 8 illustrates a top perspective view of an embodiment of a tissueinterface module.

FIG. 9 shows an exploded top perspective view of a tissue interfacemodule.

FIG. 10 is an exploded top perspective view of an embodiment of a tissueinterface module.

FIG. 11 shows a side cutaway view of a tissue interface module.

FIG. 12 illustrates a side cutaway perspective view of a tissueinterface module.

FIG. 13 is a perspective end view of an inner insert assembly from atissue interface module.

FIG. 14 is an exploded perspective side view of the inner insertassembly of FIG. 13.

FIG. 15 shows an end view of an applicator without a tissue interfacemodule attached.

FIG. 16 illustrates a cutaway view of a section of an applicator and aportion of tissue interface module.

FIG. 17A is a side cutaway view of a portion of an applicator and aportion of tissue interface module with a magnet in a first position

FIG. 17B is a side cutaway view of a portion of an applicator and aportion of tissue interface module with a magnet in a second position.

FIG. 18 illustrates a side cutaway view of a section of an applicatorand a tissue interface module as tissue is pulled into a tissueacquisition chamber by applied vacuum.

FIG. 19 shows a side cutaway view of a section of an applicator and atissue interface module showing an air path with vacuum applied.

FIG. 20 is a side cutaway perspective view of an applicator and a tissueinterface module showing some of the internal components of theapplicator, including vacuum conduits.

FIG. 21 illustrates a side cutaway perspective view of an applicatorshowing some of the internal components of the applicator.

FIG. 22 shows a side cutaway perspective view of an applicator with atissue interface module attached to the applicator and showing a portionof magnetic drive components.

FIG. 23 shows a side cutaway view of a tissue interface module.

FIG. 24 illustrates a side cutaway perspective view of a tissueinterface module.

FIG. 25 illustrates an end cutaway view of a section of an applicatorand a portion of a tissue interface module.

FIG. 26 is a side cutaway view of a portion of the applicator and aportion of a tissue interface module.

FIG. 27 illustrates a side cutaway view of a section of an applicatorand a tissue interface module as tissue is pulled into a tissueacquisition chamber by applied vacuum.

FIG. 28 shows a side cutaway view of a section of an applicator and atissue interface module showing air paths with vacuum applied.

FIG. 29 shows a side cutaway view of a tissue interface module ofanother embodiment of the invention.

FIG. 30 shows a side cutaway view of a section of an applicator and atissue interface module.

FIG. 31 is a side cutaway view of a portion of an applicator and aportion of a tissue interface module.

FIG. 32 shows a side cutaway view of a section of an applicator and atissue interface module showing an air path with vacuum applied.

DETAILED DESCRIPTION

FIG. 1 illustrates a Physician treating a patient with energy deliverysystem 110 (which may be referred to herein as system 110). Energydelivery system 110 may include a console 112, applicator 114 and tissueinterface module 116. Console 112 may be referred to herein as generator112. Applicator 114 may be referred to herein as hand piece or handpiece114. Tissue interface module 116 may also be referred to as consumable116, disposable 116, tissue interface 116, applicator tissue interface116, module 116 or bioTip 116. Console 112 may include a display 164,power cord 108, holster 120 and foot pedal switch 132. Display 164 maybe used to show a graphical user interface to guide the physicianthrough treatment steps, such graphical user interface may include, forexample, a color map of treatment temperatures, a placement countindicator and a placement positioning arrow. Applicator 114 may includecable assembly 134 and multifunction connector 136. Energy deliverysystem 110 may be configured to deliver energy to tissue, including skintissue. In some embodiments, energy delivery system 110 is configured todeliver microwave energy to the skin of the patient to treat a conditionof the skin, such as, for example, hyperhidrosis, excessive sweating,bromhidrosis, cellulite, fat, wrinkles, acne, unwanted hair or otherdermatological conditions.

When system 110 is assembled, applicator 114 may be connected to console112 via multifunction connector 136. Console 112 may be configured togenerate energy (e.g., microwave energy) at a frequency of, for example,approximately 5.8 gigahertz. Console 112 may be configured to generateenergy (e.g., microwave energy) at a frequency of, for example, betweenapproximately 5.3 gigahertz and 6.3 gigahertz or between approximately5.0 gigahertz and 6.5 gigahertz. In some embodiments, applicator 114 maybe connected to console 112 with, for example, a microwave cable, atensile cord, a USB cable, coolant tubing and vacuum tubing. Applicator114 may also be connected to a tissue interface module 116. Theseelements may be included in cable assembly 134. A foot pedal switch 132may be connected to console 112 to control one or more of the functionsof console 112, including the transmission of energy to applicator 114or, alternatively, switches or buttons on applicator 114 may be used tocontrol console 112.

In some embodiments, console 112 may also include a vacuum source, acooling fluid source, (e.g., a chiller), a cooling fluid pump, anamplifier, a microwave generator, and control circuitry. These featuresof console 112 are internal to the console and are used to generatevacuum pressure, cooling fluid and microwave energy which may betransmitted through multifunction connector 136 and cable assembly 134to applicator 114.

FIG. 2 shows a perspective view of applicator 114 with tissue interfacemodule 116 attached to a distal end of applicator 114. Cable assembly134 is shown extending from a proximal portion of applicator 114.Applicator switch 130 may be disposed on a surface of applicator 114 andmay be used to control the application of treatment energy fromapplicator 114. Applicator 114 may also include main control circuitryadapted to control LED indicators, an antenna switch, and applicatorswitch 130. In some embodiments, the main control circuitry may bedesigned to receive signals indicative of the direct or reflected powermeasured at each antenna in applicator 114.

FIG. 3 shows a perspective view of applicator 114 with tissue interfacemodule 116 detached from applicator 114. Removal of tissue interfacemodule 116 reveals electrical contacts 119, which are configured toengage electrical contacts 160 (electrical contacts 160 may be formed byconductive traces on a suitable substrate) and printed circuit board162. Electrical contacts 160 and traces on printed circuit board 162 maybe positioned on one or both sides of tissue interface module 116.Electrical contacts 160 and associated circuitry may be used to, forexample, detect the presence of tissue interface module 116 as it isbeing positioned on applicator 114 or to detect proper alignment oftissue interface module 116 when tissue interface module 116 is properlyattached to applicator 114. A security chip may also be included onprinted circuit board 162, along with electrostatic discharge (ESD)protection such as, for example, an ESD diode. An integrated circuit 163(see FIGS. 8-10) may also be included to, for example, assist indetecting the presence and/or proper alignment of tissue interfacemodule 116. In some embodiments, printed circuit board 162 andintegrated circuit 163 may be used to detect re-use of a previously usedtissue interface module 116. Such information may be used to, forexample, notify the user that a new tissue interface module should beused or prevent the re-use of a previously used tissue interface module,which may be contaminated with, for example, biological fluids from aprevious patient. Applicator 114 may further include applicator switch130. FIG. 3 also shows an end view of a multifunction connector 136disposed at the proximal end of cable assembly 134 for attachment ofapplicator 114 to console 112 of FIG. 1.

FIG. 4 shows an end view of multifunction connector 136 and cableassembly 134. In FIG. 4, multifunction connector 136 includes coolingfluid connector 224, cooling fluid return connector 225, microwaveconnector 220, electronic connectors 222 and vacuum connectors 226.Multifunction connector 136 and cable assembly 134 provide a functionalconnection between console 112 and applicator 114 (see, for example FIG.1), allowing applicator 114 to receive microwave energy, data,electrical energy, cooling fluid, and vacuum for treatment proceduresand to transmit data back to console 112.

FIG. 5 illustrates an end view of tissue interface module 116 as viewedfrom the side of tissue interface module 116 that contacts tissue.Tissue interface module 116 may include a tissue acquisition chamber 142having a tissue interface surface 200, a bio-barrier 152, vacuum notches214, and skirt 206. In some embodiments of the invention, tissueinterface surface 200 may be, for example, a distal surface ofbio-barrier 152. In some embodiments of the invention, skirt 206 may notbe used or may be modified to facilitate the acquisition of tissue.Tissue acquisition chamber 142 may be sized to facilitate tissueacquisition in the treatment region of the patient. Tissue acquisitionchamber 142 may be sized to prevent elements of tissue interface module116 from interfering with energy radiated from applicator 114. In someembodiments, tissue acquisition chamber 142 may be sized to beapproximately 1.54 inches long by 0.7 inches wide, having a depth ofapproximately 0.255 inches to 0.295 inches. Tissue acquisition chamber142 may be sized and configured such that the walls of tissueacquisition chamber 142 are outside of the outer edge of antenna array124 (see, for example FIG. 21). Tissue acquisition chamber 142 mayinclude corners having a radius of approximately 0.1875 inches at adistal end thereof. Tissue acquisition chamber 142 may include cornershaving a radius of approximately 0.29 inches at a distal end thereof. Insome embodiments, these measurements may vary by, for example, up toplus or minus twenty percent. Tissue acquisition chamber 142 is used toproperly position tissue in tissue interface module 116 and to properlyposition such tissue adjacent the distal end of applicator 114.

Skirt 206 may be made from, for example, a compliant medical gradeplastic (e.g., a thermal plastic elastomer) such as, for example,urethane, or alternatively silicone, natural or synthetic rubber,elastomeric material, urethane foam with silicone, compliant plastic ora rubber seal coating. A suitable skirt 206 may have a height of between0.15″ and 0.40″ and more specifically, approximately 0.25″ above tissueacquisition chamber 142 when skirt 206 is not compressed. In someembodiments, skirt 206 may have a durometer (hardness) of approximately60 on the Shore A scale, or between 40 and 60, or between 20 and 80 onthe Shore A scale. In one embodiment, skirt 206 may include inner wallshaving an average angle of approximately 53 degrees when not compressed.In one embodiment, skirt 206 may include inner walls having an averageangle of approximately 49 degrees when not compressed. In someembodiments, these measurements may vary by, for example, up to plus orminus twenty percent. In some embodiments, skirt 206 may be clear orsee-through to assist the physician in properly positioning applicator114 with the tissue to be treated, by, for example, aligning skirt 206with temporary markings on the patient's skin.

FIG. 6 is a top view of tissue interface module 116 from the proximal(non-treatment/applicator interface) side of tissue interface module 116which is configured to attach to an applicator 114, such as, forexample, the applicator illustrated in FIGS. 1-3. In FIG. 6, tissueinterface module 116 includes bio-barrier 152, applicator chamber 118,attachment mechanism 126, vacuum channels 138, attachment supports 127,and gasket 158. Gasket 158 may be referred to as a consumable gasket158. Attachment mechanism 126 may be, for example a magnet, aferromagnetic plate or other ferromagnetic element and may be referredto as a latch plate or consumable latch plate. Vacuum channels 138 maybe positioned at a proximal end of a tissue chamber vacuum path.Applicator chamber 118 is adapted to receive and connect to a distal endof applicator 114. In embodiments of the invention, applicator 114 mayinclude, for example, a microwave antenna, a cooling element or coolingplate, and at least one vacuum inlet. Gasket 158 may provide asubstantially air tight (e.g., hermetic) seal against applicator 114when a distal end of applicator 114 is positioned in applicator chamber118. In embodiments of the invention, the seal provided by gasket 158may allow a limited amount of air to pass, provided that such leaks donot adversely affect the vacuum balance described herein or otherwiseadversely affect the function of the tissue interface module. In someembodiments, a proximal end of gasket 158 may form a sealing member.Gasket 158 may have a hardness durometer of, for example, between 20 Aand 80 A. Gasket 158 may also have a thickness of approximately 1/16thof an inch in some embodiments. In some embodiments, these measurementsmay vary by, for example, up to plus or minus twenty percent. Theopening formed by gasket 158 at the proximal end of applicator chamber118 may act as a vacuum interface 504 (which may also be referred to asa vacuum outlet, vacuum outlet opening, vacuum channel or vacuum channelopening) when tissue interface module 116 is positioned on applicator114, air is channeled to flow out from applicator chamber 118 and intovacuum inlets 174 on applicator 114. Positioning vacuum interface 504 ata proximal end of tissue interface module 116, in applicator chamber118, may be particularly beneficial as it helps to maintain the pressurein applicator chamber 118 (P_(app)) at a pressure less than the pressurein the tissue acquisition chamber 142 (P_(tiss)), which helps to ensurethat bio-barrier 152 will maintain its position against cooling plate128. This position may be maintained even in the presence of leaks, suchas, for example, leaks at the interface between gasket engagementsurface 500 and sealing surface 121. This arrangement may beparticularly important in preventing the formation of bubbles, voids ordeformities in the interface between bio-barrier 152 and applicatortissue treatment surface 502 (which may be, for example, the distalsurface of cooling plate 128) thus protecting the patients skin fromdamage resulting from such bubbles, voids or deformities.

Attachment mechanisms 126 may be positioned on proximal side of tissueinterface module 116, such as, for example in applicator chamber 118 andbe adapted to facilitate the attachment of module 116 to applicator 114.In some embodiments, attachment mechanism 126 may include mechanicalelements on applicator 114 and tissue interface module 116. In someembodiments, attachment mechanisms 126 may include a metal orferromagnetic plate configured to cooperate with a magnet or magnets onapplicator 114. In some embodiments, attachment mechanisms 126 form acompleted magnetic circuit with elements of applicator 114, including,for example, magnet 186 and magnetic extenders 179 (see, for example,FIGS. 17A and 17B). Magnet 186 in cooperation with magnetic extenders179 may form at least a portion of a magnetic clamp adapted to engageand hold tissue interface module 116 in position during treatment of apatient. Magnet 186 may be, for example, a diametrically magnetizedneodymium cylindrical magnet. Attachment mechanism 126 may be, forexample, stainless steel plates, ferromagnetic plates, iron plates orsteel plates. In some embodiments, attachment mechanisms 126 may be, forexample, plates approximately 0.5 inches in width and 1.05 inches inlength, with a thickness of approximately 0.63 inches. The size of theseplates may, without substantial impact to performance, vary in otherembodiments by, for example, plus or minus 20%. However, thicker and/orlarger magnetic plates may increase the mass of the plate withoutimproving the magnetic holding force, having the potentially undesirableeffect of making vacuum leaks more likely or making tissue interfacemodule 116 more likely to fall or be knocked off applicator 114. Thinnerand/or smaller magnetic plates may reduce the magnetic holding force,also having the undesirable effect of making vacuum leaks more likely ormaking tissue interface module 116 more likely to fall or be knocked offapplicator 114. Attachment mechanisms 126 may rest upon attachmentsupports 127, which keep attachment mechanisms 126 elevated above andprevent attachment mechanisms 126 from restricting the flow of airthrough vacuum channels 138 and a filter 154 (see, for example, FIG. 9).In some embodiments, attachment supports 127 are adapted to keepattachment mechanisms 126 raised approximately 0.010 inches (or, in someembodiments 0.080 inches) above filter(s) 154, optimizing air flowthrough vacuum channels 138 without substantially increasing the size oftissue interface module 116. In some embodiments, these measurements mayvary by, for example, up to plus or minus twenty percent.

FIG. 7 is a top perspective view of tissue interface module 116, alsoshowing the proximal (non-treatment) side of tissue interface module116. FIG. 7 shows applicator chamber 118, which is adapted to receiveand properly position applicator 114 with respect to bio-barrier 152when tissue interface module is 116 attached to applicator 114. Whentissue interface module 116 is attached to applicator 114, applicatorchamber 118 is adapted to receive a distal end of applicator 114,including, for example, a microwave antenna, a cooling element orcooling plate, and a vacuum inlet. Gasket 158 may provide a seal betweentissue interface module 116 and applicator 114 when tissue interfacemodule 116 is attached to applicator 114. Gasket 158 may be held inplace by attachment mechanisms 126. Gasket 158 may, in some embodiments,form at least a portion of vacuum interface 504. Gasket 158 may, in someembodiments, surround vacuum interface 504. A gasket engagement surface500, which, in one embodiment of the invention may be located at aproximal end of gasket 158, may be positioned such that gasketengagement surface 500 contacts sealing surface 121 on applicator 114 astissue interface module 116 is attached to applicator 114. Tissueinterface module 116 may be further designed to engage applicator 114 ina manner which causes gasket engagement surface 500 to deflect as itcontacts sealing surface 121. The deflection of gasket engagementsurface 500 increases the area of gasket engagement surface 500 incontact with sealing surface 121 and, thus, improving the seal betweengasket 158 and applicator 114. As described above, the interior oftissue interface module 116 may further include electrical contacts 160and printed circuit board 162 configured to, for example, detect thepresence of tissue interface module 116 and/or proper alignment oftissue interface module 116 with applicator 114.

Also shown in FIG. 7 is skirt 206, which is configured to facilitate theengagement of tissue, and alignment marker 208 disposed on skirt 206 foraligning tissue interface module 116 with specific portions of thetissue to be treated. During therapy, stamps or markings, including, forexample, temporary tattoos may be used to mark patient tissue toappropriately place applicator 114 during treatment. Such stamps may besized to overlay an area to be treated, (e.g., an axilla). When used onan axilla, a physician may need to select different stamp sizes fordifferent axilla sizes. Stamps are used to mark a number of differenttreatment points on a patient, including, for example, anesthesiainjection sites. Physicians may use the marks created on the patientsskin to properly place applicator 114 before and during treatment,using, for example alignment marker 208 on skirt 206.

FIG. 8 is a top perspective view of an embodiment of a tissue interfacemodule 116. In this embodiment, printed circuit board 162, electricalcontacts 160, and integrated circuit 163 are positioned on the sameside(s) of tissue interface module 116 as attachment mechanism 126. Asin FIG. 7, skirt 206, alignment marker 208, bio-barrier 152, gasket 158,and applicator chamber 118 may also be seen in this alternativeembodiment. FIG. 8 also illustrates attachment mechanism 126, gasketengagement surface 500 and vacuum interface 504.

FIG. 9 is an exploded top perspective view of the tissue interfacemodule 116 of FIGS. 5-7. In FIG. 9, the tissue interface module 116 mayinclude an outer shell 193 and an inner insert 192 and may, in someembodiments also include a reflector 166. Inner insert 192 may include,for example, bio-barrier 152, filters 154, attachment mechanisms 126,gasket 158, vacuum channels 138, attachment supports 127 and applicatorchamber 118. Outer shell 193 may include, for example, electricalcontacts 160, printed circuit board 162, integrated circuit 163,insulating cover 168, alignment marker 208 and skirt 206.

As shown in FIG. 9, one or more filters 154 may be positioned on eitheror both sides of bio-barrier 152. Membranes or filters suitable for useas filters 154 may include membranes which are permeable to air butsubstantially impermeable to biological fluids. Membranes or filterssuitable for use as filters 154 may include membranes which providesufficient resistance to the flow of air to ensure a pressuredifferential between a first and a second side of filters 154 as airflows through filters 154. When air is removed from applicator 114through applicator chamber 118 (see, e.g., FIGS. 2-3), filters 154 allowair or gas but not fluid or tissue to pass (see, e.g., FIG. 5). A vacuumin applicator chamber 118 pulls air through filters 154, creating avacuum in tissue acquisition chamber 142 to pull tissue positionedadjacent tissue acquisition chamber 142 into tissue acquisition chamber142 and position that tissue against bio-barrier 152 and tissueinterface surface 200. Hence the creation of a vacuum in applicatorchamber 118 pulls tissue into tissue interface module 116 and positionsthat tissue for treatment by applicator 114.

Referring still to FIG. 9, reflector 166 may optionally be positionedbetween inner insert 192 and outer shell 193, or integrated into innerinsert 192, outer shell 193, or both. Reflector 166 may include anelectrically conductive mesh with openings of a predetermined size. Insome embodiments, reflector 166 is configured to isolate strayelectromagnetic fields and reflect stray electromagnetic energy backinto applicator 114. In some embodiments, reflector 166 is positioned soas to be electrically isolated from applicator 114 and electricallyisolated from tissue positioned in tissue acquisition chamber 142.Reflector 166 may be sized and configured to surround at least a portionof and preferably most or all of tissue interface surface 200 whentissue interface module 116 is positioned on applicator 114. Reflector166 may be sized and configured to surround at least a portion of andpreferably most or all of distal surface of cooling plate 128. In someembodiments, reflector 166 may include a metallic mesh material of wirehaving a diameter of approximately 0.008 inches with wires arranged in amesh of approximately 30 by 30 wires per inch. In some embodiments,reflector 166 may include a metallic mesh having wires arranged in amesh of approximately 100 by 100 exch. In some embodiments, thesemeasurements may vary by, for example, up to plus or minus twentypercent.

FIG. 10 is an exploded top perspective view of tissue interface module116 of FIG. 8. In FIG. 10, tissue interface module 116 may include anouter shell 193 and an inner insert 192. Inner insert 192 may includebio-barrier 152, filter(s) 154, attachment mechanisms 126, gasket 158,vacuum channels 138, attachment supports 127, applicator chamber 118,electrical contacts 160, printed circuit board 162, integrated circuit163, tab member 146, and latch openings 147. Outer shell 193 may includealignment marker 208 and skirt 206. Reflector 166 may optionally bepositioned between inner insert 192 and outer shell 193, or integratedinto inner insert 192, outer shell 193, or both. The embodimentsdescribed herein are particularly advantageous because of theimprovements they provide in manufacturability, quality, cost andmanufacturing time.

FIG. 11 illustrates a side cutaway view of a tissue interface module 116and FIG. 12 shows a side cutaway perspective view of tissue interfacemodule 116. The tissue interface module illustrated in FIGS. 11 and 12may include many of the features described herein, including tissueacquisition chamber 142, bio-barrier 152, filters 154, applicatorchamber 118, electrical contacts 160, printed circuit board 162,attachment mechanism 126, gasket 158, gasket engagement surface 500,inner insert 192, outer shell 193, reflector 166, skirt 206, acquisitionchamber opening 143, vacuum notches 214 (not shown in FIG. 12) andtissue interface surface 200 (not shown in FIG. 12). Attachmentmechanisms 126 include engagement surface 125, which is configured toengage with cooperative elements on applicator 114 of FIGS. 2 and 3(e.g., via magnetic attachment). In FIG. 11, engagement surface 125 mayform an angle X with a plane formed by bio-barrier 152. Angle X may alsobe measured as the angle between engagement surface 125 and a planethrough or parallel to applicator treatment surface 502 when tissueinterface module 116 is positioned on applicator 114 (see, for example,the position of applicator treatment surface 502 FIG. 17A).

As described herein, attachment mechanisms 126 may be disposed onattachment supports 127 of FIG. 6 over vacuum channels 138 of FIGS. 6and 9. Filters 154 may be positioned on the other side of attachmentsupports 127 and vacuum channels 138. In addition to the featuresdescribed above, tissue interface module 116 may further include fluidtraps 156 integrated into tissue interface module 116. (Fluid trap 156may also be referred to as a vacuum trap, vacuum reservoir or integratedfluid trap). Fluid traps 156 may be configured to, for example, trapcontaminants such as tissue, bodily fluids or lubricants before suchcontaminants reach filter 154. In embodiments of the invention, tissueinterface module 116 may include at least one expandable aperture 170(also referred to as a variable flow restrictor or expandable channel)between tissue acquisition chamber 142 and fluid traps 156.

Fluid traps 156 may be configured to, for example, collect blood, sweat,and any other bodily fluids or tissue that may collect within tissueinterface module 116 during treatment. Fluid traps 156 may furthercollect liquids or jells, such as, for example, K-Y jelly, used tofacilitate acquisition of tissue. By collecting bodily fluids or tissuesin fluid traps 156, tissue interface module 116 keeps filters 154 clearfrom obstructions that would otherwise interfere with the flow of airthrough such filters and might interfere with treatment or rendertreatment impossible. Thus, filters 154 are disposed between, andcommunicating with, both applicator chamber 118 and tissue acquisitionchamber 142. As described above, filters 154 may include openingsconfigured to permit air or gas to pass but prevent liquid from passingthrough filters 154. In one embodiment, applicator chamber 118 is ableto communicate with tissue acquisition chamber 142 via filters 154 andvacuum channels 138. Tissue interface module 116 may further includevacuum interface 504.

Expandable aperture 170 may be included at a proximal end of tissueacquisition chamber 142, and expandable aperture 170 may include, forexample, a gap at top of tissue acquisition chamber 142 between abio-barrier 152 and an interior rim of tissue acquisition chamber 142.Vacuum notches 214 may be included in tissue acquisition chamber 142proximal to the gap to enhance vacuum acquisition. In some embodiments,one wall (such as, for example, the wall formed by bio-barrier 152) ofexpandable aperture 170 may be flexible to increase in size and increaseairflow when vacuum is applied. A tissue treatment surface 200 ofapplicator 114 may act to restrict the width of the aperture as itexpands. A suitable expandable aperture 170 may be sized to allow air topass into a vacuum path while preventing tissue from blocking suchvacuum path.

FIG. 13 illustrates a perspective end view of inner insert 192, showingtissue interface surface 200, bio-barrier 152, filters 154, and gasket158. This view of inner insert 192 shows the portions of filters 154which interface with and help form fluid traps 156 (see, e.g., FIGS.11-12). In one embodiment of the invention (with tissue interface module116 positioned on applicator 114 and tissue positioned adjacentacquisition chamber opening 143) all airflow exchange between applicatorchamber 118 and tissue acquisition chamber 142 flows through theinterior of tissue interface module 116. In one embodiment of theinvention (with tissue interface module 116 positioned on applicator 114and tissue positioned adjacent acquisition chamber opening 143) allairflow exchanged between applicator chamber 118 and tissue acquisitionchamber 142 flows through filters 154. Maximizing the surface area offilters 154 may increase vacuum performance and provide redundancy incase one of filters 154 becomes clogged with, for example, biologicaltissue, lubricants or bodily fluids. In one embodiment, filters 154 mayoccupy approximately the same surface area as bio-barrier 152. In otherembodiments, a functional portion of bio-barrier 152 may occupyapproximately 60% (in some embodiments 50-70%), of the functionalsurface area of bio-barrier 152, and a functional portion of filters 154may occupy the remaining 30-50% of the total bio-barrier functionalsurface area. With respect to bio-barrier 152, the functional area maybe the area of bio-barrier 152 which comes into contact with the distalside of cooling plate 128. With respect to filter 154, the functionalarea may be the area of filter 154 through which air travels as air ispulled from tissue acquisition chamber 142 into applicator chamber 118.In some embodiments of the invention, a combined bio-barrier, includingbio-barrier 152 and filters 154 may include a functional area which isapproximately fifty to seventy percent composed of bio-barrier 152 andapproximately thirty to fifty percent composed of filters 154.

FIG. 14 is an exploded perspective side view of inner insert 192,revealing vacuum channels 138 and attachment supports 127 behind filters154. As described above, vacuum channels 138 allow for airflow underattachment mechanisms 126 (see, e.g., FIG. 6) and through filters 154,to allow for vacuum communication between applicator chamber 118 (see,e.g., FIG. 6) and tissue acquisition chamber 142 (see, e.g., FIG. 5) oftissue interface module 116 (see, e.g., FIG. 2). Inner insert 192further includes bio-barrier 152 and gasket 158.

FIG. 15 shows an end view of applicator 114 without tissue interfacemodule 116 (see, e.g., FIG. 2) attached. Applicator 114 may includeelectrical contacts 119 for electrical coupling with electrical contacts160 and printed circuit board 162 (see, e.g., FIG. 7) of tissueinterface module 116. Applicator 114 may further include cooling plate128, applicator vacuum inlets 174, applicator tissue treatment surface502, aesthetic features 175 and applicator engagement surface 178.Applicator engagement surfaces 178 are configured to engage attachmentmechanisms 126 of tissue interface module 116. Applicator engagementsurface 178 may include a first applicator engagement surface 178Apositioned at a distal end of a first magnetic extender 179 (see FIG.17A) and a second applicator engagement surface 178B positioned at adistal end of a second magnetic extender 179. Applicator vacuum inlets174 are coupled to a vacuum source in console 112. When tissue interfacemodule 116 is attached to applicator 114 (see, e.g., FIG. 15),applicator vacuum inlets 174 are configured be positioned in applicatorchamber 118 (see, e.g., FIG. 6) and to evacuate air from applicatorchamber 118 through, for example, vacuum interface 504, creating avacuum in applicator chamber 118 and pulling air through filters 154(see FIG. 9) from through tissue acquisition chamber 142 (see, e.g.,FIG. 5).

Cooling plate 128 of applicator 114 may include an alumina or othermetal frame surrounding the back side of cooling plate 128 to addstructural strength to cooling plate 128, a plurality (e.g., four) ofthreaded rods may be bonded to the alumina frame to cooling plate 128 toa waveguide holder (not shown). In some embodiments, cooling plate 128may comprise a ceramic material having approximately 94 to 99 percentalumina and 1 to 6 percent other material. Cooling plate 128 may furtherinclude one or more thermocouple traces (of, for example, copper andconstantan). These thermocouples may be arranged to detect a temperatureof cooling plate 128, a temperature of the surface of the tissue to betreated or a temperature of the interface. Such traces may be routed inside by side pairs to, for example, reduce the effect of noise on theoutput of such thermocouples. Such traces may be aligned to beperpendicular to the e-field emitted from the applicator to prevent thethermocouple traces from disrupting the e-field. When applicator 114 isattached to tissue interface module 116, applying vacuum to tissueinterface module 116 may result in pulling bio-barrier 152 of FIG. 5 oftissue interface module 116 against cooling plate 128 of applicator 114.

FIG. 16 shows a side cutaway view of a section of applicator 114 and aportion of tissue interface module 116, including gasket 158, attachedto applicator 114. In FIG. 16, the side angle shows how skirt 206 andtissue interface surface 200 form at least a portion of tissueacquisition chamber 142. A portion of a vacuum flow path according to anembodiment may also be seen in FIG. 16, including, for example, tissueacquisition chamber 142, expandable aperture 170, and fluid trap 156. Avacuum path according to an embodiment may further include vacuuminterface 504. Also shown are coolant conduits 185 of applicator 114,which supply cooling fluid to cool applicator cooling plate 128. Coolantconduits 185 may include antimicrobial fittings and tubing using, forexample, natural silver ion implanted antimicrobial tubing manufacturedby Eldon James such as, for example Flexelene™. Such fittings and tubingmay provide protection against microbial colonization (e.g., bacteria,mildew, mold and fungi). The tubing for conduits 185 may also be adaptedto provide protection against microbial colonization without impacting,reducing or modifying the microwave characteristics (e.g., losscharacteristics) of cooling fluid passing through such antimicrobialfittings and tubing.

FIGS. 17A-17B are side cutaway views of a portion of applicator 114 anda portion of tissue interface module 116 attached to applicator 114. InFIGS. 17A-17B, applicator 114 includes magnet 186 which may be rotatableor otherwise movable and may be configured to complete a magneticcircuit between magnetic extenders 179 and attachment mechanism 126 toattach tissue interface module 116 to applicator 114. Applicator 114further includes antenna array 124. Completing the magnetic circuitbetween magnetic extenders 179 and attachment mechanism 126 magneticallycouples attachment mechanism 126 on tissue interface module 116 tomagnetic extenders 179 on applicator 114. Magnet 186 may be coupled to arotation mechanism such as a direct current gear motor or an RCservomotor, so as to rotate magnet 186 within magnetic extenders 179between a position which results in an incomplete magnetic circuit and aposition which results in a completed magnetic circuit. In FIG. 17A, the“N” and “S” poles of magnet 186 are shown in the vertical position,resulting in an incomplete magnetic circuit by not completing themagnetic circuit with magnetic extenders 179 and attachment mechanism126. When the magnetic circuit is incomplete, there is little or nomagnetic attraction between attachment mechanism 126 and magneticextenders 179, facilitating removal of tissue interface module 116 fromapplicator 114. In FIG. 17B, the “N” and “S” poles of magnet 186 havebeen rotated into the horizontal position, thereby completing themagnetic circuit and magnetically attaching magnetic extenders 179 toattachment mechanism 126. In some embodiments, a stop may be implementedusing a hall-effect position sensor or a hard stop. In some embodimentsof the invention, magnet 186 may be positioned to partially complete themagnetic circuit prior to or as tissue interface module 116 is attachedto applicator 114 to facilitate proper seating of tissue interfacemodule 116. Once tissue interface module 116 is properly seated onapplicator 114, magnet 186 may be positioned to fully close the magneticcircuit, holding tissue interface module 116 in place.

Other features of tissue interface module 116 but shown in FIGS. 17A and17B include gasket 158, expandable aperture 170, fluid trap 156, tissueinterface surface 200, skirt 206, tissue acquisition chamber 142,bio-barrier 152, filter 154, outer shell 193, reflector 166, andattachment mechanisms 126. Also shown, a sealing surface 121 (which mayalso be referred to as a gasket contact surface) of applicator 114 maybe angled to receive gasket 158 from tissue interface module 116. Inthis embodiment, placing sealing surface 121 at an angle, causes gasket158 to bend when tissue interface module 116 is attached to applicator114, improving the sealing characteristics by maximizing the contactsurface between gasket 158 and sealing surface 121 and reducing theforce required to attach the tissue interface module 116 to theapplicator 114. Also illustrated are cooling plate 128, applicatortissue treatment surface 502 and vacuum interface 504.

In FIG. 18, applicator 114 includes magnetic extenders 179, magnet 186,sealing surface 121 and cooling plate 128. Tissue interface module 116includes gasket 158, expandable aperture 170, fluid trap 156, skirt 206,tissue acquisition chamber 142, bio-barrier 152, filter 154, outer shell193, reflector 166, attachment mechanism 126 and tissue interfacesurface 200. Also illustrated is vacuum interface 504. Tissue (includingepidermis 410, dermis 412, dermal-hypodermal interface 414, hypodermis416 and muscle 418) is shown positioned partially within tissueacquisition chamber 142. In FIG. 18 applicator 114 and tissue interfacemodule 116 of FIGS. 17A-17B have been placed in contact with tissue. InFIG. 18 vacuum pressure has been initiated and air is being drawn fromapplicator chamber 118, resulting in a drop in pressure in applicatorchamber 118 and in tissue acquisition chamber 142. In FIG. 18, thetissue (including epidermis 410, dermis 412, dermal-hypodermal interface414 and hypodermis 416) is shown being pulled into tissue acquisitionchamber 142. As tissue is pulled into tissue acquisition chamber 142 itmoves towards tissue interface surface 200 and bio-barrier 152. Pullingtissue into tissue acquisition chamber 142 may also provide a benefit ofmoving structures in the dermis and hypodermis away from deeperstructures such as, for example, muscles and nerves. Vacuum pressureapplied by applicator 114 to applicator chamber 118 of tissue interfacemodule 116 may be adapted to localize and stabilize tissue located intissue acquisition chamber 142. When tissue is fully engaged in tissueacquisition chamber 142, the vacuum pressure is also adapted to holdtissue positioned in tissue acquisition chamber 142 against tissueinterface surface 200 and bio-barrier 152. Additionally, vacuum intissue acquisition chamber 142 pulls bio-barrier 152 into contact withcooling plate 128, so as to ensure the efficient transfer of coolingenergy to the epidermis 410 and underlying tissue during application ofmicrowave energy. In some embodiments of the invention, the vacuum isconfigured to have a flow rate of approximately 13.7 Standard FluidLiters Per Minute during tissue acquisition which flow rate may, in someembodiments, vary by up to plus or minus twenty percent.

In one particular embodiment, as shown in FIG. 18, the vertical distance90 from gasket engagement surface 500 (which in one embodiment may bethe top of gasket 158) to a first connection point 590 on engagementsurface 125 of FIGS. 11-12 of the uppermost portion of attachmentmechanism 126 is approximately 0.15″. In one embodiment, the verticaldistance 92 from gasket engagement surface 500 to a second connectionpoint 592 on engagement surface 125 of the portion of attachmentmechanism 126 that intersects the inside of the left magnetic extender179 is approximately 0.22″. In one embodiment the vertical distance 94from gasket engagement surface 500 to a third connection point 594 onengagement surface 125 of the portion of attachment mechanism 126 thatintersects the inside of the right magnetic extender 179 isapproximately 0.27″. And, in a further embodiment, the vertical distance96 from gasket engagement surface 500 to a fourth connection point 596on at the lower portion of engagement surface 125 of attachmentmechanism 126 is approximately 0.34″. In some embodiments thesemeasurements may vary by, for example, up to ±0.01″. In someembodiments, these measurements may vary by ±0.05″.

In one embodiment, the angle of engagement surface 125 of attachmentmechanism 126 may be identical or substantially identical (in oneembodiment, within, for example, five degrees) to the angle ofapplicator engagement surface 178 at a distal end of magnetic extenders179 to provide a flush fit between the extenders and the attachmentmechanism 126 when the tissue interface module 116 is attached to theapplicator 114. In one embodiment, the angle of applicator engagementsurfaces 178 may be arranged to be parallel or substantially parallel(in one embodiment within, for example, up to five degrees of parallel)to engagement surfaces 125 of attachment mechanism 126 to provide aflush fit between the extenders and the attachment mechanism 126 whentissue interface module 116 is attached to the applicator 114. In oneembodiment of the invention engagement surface 125 may be sized andarranged to maximize the portion of engagement surface 125 contacted byapplicator engagement surface 178. In one embodiment of the invention, afirst portion of engagement surface 125 is arranged to contact a firstapplicator engagement surface 178A and a second portion of engagementsurface 125 may be sized and arranged to contact a second applicatorengagement surface 178B.

In one embodiment of the invention engagement surface 125 may be sizedand arranged to form a ferromagnetic bridge between applicatorengagement surface 178A and 178B when tissue interface module 116 ispositioned on applicator 114. In one embodiment of the inventionengagement surface 125 may be sized and arranged to form a closedmagnetic circuit with applicator engagement surface 178A and 178B whentissue interface module 116 is positioned on applicator 114.

In FIG. 18 expandable aperture 170 may be configured to expand whenvacuum is applied by an applicator 114 to applicator chamber 118 and totissue acquisition chamber 142 with tissue interface module 116 attachedto applicator 114. In some embodiments, the application of vacuum totissue interface module 116 at vacuum interface 504 pulls bio-barrier152 inwards towards cooling plate 128 of applicator 114, which increasesthe size of expandable aperture 170. FIGS. 17A and 17B illustrateembodiments of the invention wherein bio-barrier 152 is in its un-flexedstate and expandable aperture 170 is at its minimum width. In FIG. 18,expandable aperture 170 has been opened to its maximum width by theapplication of vacuum pressure to applicator chamber 118, which pullsbio-barrier 152 against applicator tissue treatment surface 502 (see,e.g., FIG. 15), which, in one embodiment may be cooling plate 128. Astissue is pulled into and air is pulled out of tissue acquisitionchamber 142 a small vacuum pressure differential is maintained by thedrop in pressure across filter 154 resulting from air flowing throughfilter 154 such that the pressure in applicator chamber 118 is less thanthe pressure in tissue acquisition chamber 142. This pressuredifferential may be used to, for example, maintain the position ofbio-barrier 152 against cooling plate 128 during the acquisition oftissue. This pressure differential may further be used to ensure thatbio-barrier 152 is positioned against cooling plate 128 prior to tissuecontacting tissue interface surface 200. This pressure differential mayfurther be used to ensure that bio-barrier 152 is positioned againstcooling plate 128 without bubbles, voids or deformities. This pressuredifferential may further be used to ensure that tissue being pulled intotissue acquisition chamber 142 does not move or deform bio-barrier 152.Once the air is removed from tissue acquisition chamber 142 and replacedby tissue, air will no longer flow through filter 154 into applicatorchamber 118 and the pressure in the two chambers will be balanced orsubstantially balanced (e.g., having a pressure differential of lessthan approximately 4 pounds per square inch). With tissue properlypositioned in applicator chamber 118, the tissue pressing against tissueinterface surface 200 may be used to maintain position of bio-barrier152 against cooling plate 128, preventing, for example, the formation ofvoids, bubbles or deformities which could result in hot spots. In someembodiments of the invention, applicator 114 may be positioned inapplicator chamber 118 in a manner wherein cooling plate 128, or someother feature of tissue interface module 116, contacts bio-barrier 152prior to the application of vacuum, preventing expandable aperture 170from opening when vacuum is applied.

FIG. 19 is a side cutaway view of applicator 114 and tissue interfacemodule 116 of FIGS. 17-18 showing air paths A and B through tissueinterface module 116 with vacuum applied. Vacuum may be applied byapplicator 114 directly to applicator chamber 118 (through, for example,vacuum interface 504) of tissue interface module 116 to create vacuumwithin applicator chamber 118, as well as within tissue acquisitionchamber 142. A first vacuum flow path A extends from tissue acquisitionchamber 142, through expandable aperture 170, into fluid trap 156,through filter(s) 154, through vacuum channels 138 and into applicatorchamber 118 and into applicator 114. Second vacuum flow path B showsvacuum being pulled directly from applicator chamber 118. Fromapplicator chamber 118, air is pulled into applicator 114 through, forexample, vacuum interface 504. When vacuum is created along flow path A,tissue positioned at acquisition chamber opening 143 may be pulled intotissue acquisition chamber 142, as shown in FIG. 18. Tissue, lubricantsor bodily fluids, such as blood or sweat, may collect in fluid trap 156and those not captured in fluid trap 156 may be stopped by filter 154.Since filters 154 are permeable to air or gas but not to liquid, vacuummay be pulled through filters 154 without contaminating applicatorchamber 118 or the surface of applicator 114. The vacuum air paths A andB may be used to equalize or substantially equalize pressure (in someembodiments equalize to, for example, within four pounds per squareinch) on both sides of filter 154 (i.e., the pressure in tissueacquisition chamber 142 and applicator chamber 118). In one embodimentof the invention the resistance to airflow is higher in vacuum path Athan in vacuum path B, ensuring that, as long as air is flowing invacuum path A, the air pressure in applicator chamber 118 will be lowerthan the air pressure in tissue acquisition chamber 142. In oneembodiment of the invention, filter 154 provides resistance to the flowof air in vacuum path A, ensuring that, as long as air is flowing invacuum path A, the air pressure in applicator chamber 118 will be lowerthan the air pressure in tissue acquisition chamber 142.

In some embodiments, the vacuum flow path is completely internal totissue interface module 116 and applicator 114, originating inapplicator 114 itself, and pulling vacuum from applicator chamber 118,through filters 154, through fluid traps 156, through expandableaperture 170, and finally through tissue acquisition chamber 142 toengage tissue in tissue acquisition chamber 142. In some embodiments,the vacuum flow path hooks up directly from applicator chamber 118 oftissue interface module 116 to vacuum inlets 174 of applicator 114,without requiring an external attachment from tissue interface module116 to applicator 114 or to a separate vacuum source. In one embodiment,the vacuum path may include at least one portion having a gap width ofapproximately 0.036 inches. In one embodiment, the minimum gap width atany point along vacuum path A may be approximately 0.036 inches. In oneembodiment, the smallest dimension in a cross section of the airflowpathway along vacuum path A will be approximately 0.036 inches. In someembodiments, these measurements may vary by, for example, up to plus orminus twenty percent. In one embodiment of the invention, the smallestcross section in vacuum path A will be the cross section formed on afirst side by expandable aperture 170.

When using tissue interface module 116 vacuum may be achieved andmaintained when tissue interface module 116 is attached to applicator114, forming a seal between tissue interface module 116 and applicator114, and tissue is engaged by tissue acquisition chamber 142 (as shownin FIG. 18) forming a seal between the engaged tissue and skirt 206.Tissue interface module 116 may include one or more vacuum balancepathways designed therein. One vacuum balance path may include tissueacquisition chamber 142, fluid trap 156 and at least one filter 154adapted to allow air to pass without allowing other fluids to pass. Anexpandable aperture 170 forming an entrance to fluid trap 156 may alsobe included and may be flexible to allow the entrance to fluid trap 156to open, creating a wider gap when vacuum is applied. A reflector 166may further be included in the vacuum path as, for example, a portion offluid trap 156.

In one embodiment of the invention, when using tissue interface module116, and particularly as tissue is pulled into tissue acquisitionchamber 142, a balance or approximate balance between air pressure inapplicator chamber 118 and tissue acquisition chamber 142 may bemaintained. In one embodiment of the invention the air pressure inapplicator chamber 118 may be, for at least a period of time, at apressure below the air pressure in tissue acquisition chamber 142. Inone embodiment of the invention, when using tissue interface module 116,and particularly as tissue is pulled into tissue acquisition chamber142, a balance may be maintained wherein air pressure in applicatorchamber 118 is slightly lower than an air pressure in tissue acquisitionchamber 142. An applicator chamber 118 may be designed and configured toallow applicator 114, when inserted into applicator chamber 118 to forman airtight seal around applicator chamber 118 (e.g., with a gasket 158)and to position a distal end of applicator 114 (e.g., cooling plate 128application surface) within a predetermined distance (e.g.,approximately 0.026 inches) of bio-barrier 152. A first balance path(e.g., Path B in FIG. 19) may be created by the direct interconnectionbetween applicator 114 and applicator chamber 118 such that air pulledfrom applicator chamber 118 travels directly into applicator 114 throughvacuum inlets 174. A second balance path (e.g., Path A in FIG. 19) maybe created by the indirect interconnection between applicator 114 andtissue acquisition chamber 142, wherein air from tissue acquisitionchamber 142 must pass through at least filter 154 before being pulledinto applicator 114 through vacuum inlets 174. First and second balancepaths may combine in applicator chamber 118. In one embodiment, airbeing evacuated from tissue acquisition chamber 142, through filter 154may flow past one or more magnetic plates forming attach mechanism 126.In one embodiment of the invention, applicator 114 may further includeantenna array 124, magnetic extenders 179, and tissue interface surface200. In one embodiment of the invention tissue interface module 116 mayfurther include engagement surface 125, outer shell 193, skirt 206 andgasket engagement surface 500.

FIG. 20 shows a side cutaway view of a portion of the distal end ofapplicator 114, showing some of the internal components of applicator114, including applicator logic circuits 181, microwave feed cables 182,coolant conduits 185, vacuum conduits 184, antenna array 124, sealingsurface 121 and magnetic drive 187. Magnetic drive 187 may include, forexample, DC motors to position magnets 186 (e.g., by rotating magnets186) and hall-effect sensors to sense the position of magnets 186. FIG.20 also includes a cutaway view of tissue interface module 116,including applicator chamber 118, bio-barrier 152, vacuum interface 504,filter 154 and tissue acquisition chamber 142. As shown, applicatorchamber 118 of tissue interface module 116 is adapted and configured toreceive the distal end of applicator 114, positioning antenna array 124,cooling plate 128 and vacuum inlets 174 in applicator chamber 118.

FIG. 21 is a side cutaway perspective view of applicator 114 showingsome of the internal components of applicator 114, including applicatorlogic circuits 181, microwave feed cables 182, coolant conduits 185,vacuum conduits 184, antenna array 124, microwave switch 180 andmagnetic drive 187.

FIG. 22 is a side cutaway perspective view of applicator 114 with tissueinterface module 116 attached showing a portion of magnetic drivecomponents, including magnetic drive 187. Magnetic drive 187 may be usedto open a magnetic circuit by, for example, positioning magnet 186 inthe position illustrated in FIG. 17A with respect to extenders 179.Magnetic drive 187 may be used to complete a magnetic circuit by, forexample, positioning magnet 186 in the position illustrated in FIG. 17Bwith respect to extenders 179. With magnet 186 positioned as illustratedin FIG. 17B, tissue interface module 116 may be magnetically attached toapplicator 114.

In some embodiments, engagement surface 125 forms an Angle X (see FIG.11) of approximately 22.5 degrees from horizontal (e.g., from a planethrough bio-barrier 152 when bio-barrier 152 is un-flexed) so as tocouple to mating attachment points on applicator 114, such as, forexample, applicator engagement surfaces 178 at a distal end of magneticextenders 179. In other embodiments, engagement surface 125 forms anAngle X of between approximately 17.5 degrees and 27.5 degrees, oralternatively, an Angle X of between approximately 12.5 degrees and 32.5degrees. In other embodiments, Angle X of engagement surface 125 mayvary, up to and including 45 degrees or more, depending upon the anglechosen for the mating engagement surfaces on applicator 114. Inembodiments of the invention, applicator engagement surfaces 178 onapplicator 114 are designed to be parallel to engagement surface 125when tissue interface module 116 is properly positioned on applicator114. Creating an engagement surface 125 which conforms to the matingsurface (e.g., applicator engagement surface 178) on applicator 114 maybe important to ensure the maximum surface area of contact betweenengagement surface 125 and mating surfaces on applicator 114. Ensuringmaximum surface area contact may, for example, maximize the magneticforce applied to hold tissue interface module 116 in place and preventtissue interface module 116 from shifting or falling off of applicator114 during treatment. In some embodiments Applicator engagement surface178 may extend a predetermined distance from the outer surface ofapplicator 114 to ensure proper contact between applicator engagementsurfaces 178 and engagement surface 125 and proper positioning of gasketengagement surface 500 of gasket 158 against sealing surface 121.Maximizing the magnetic force will also provide optimum compression ofgasket 158 when it is positioned against the outer surface of applicator114, preventing vacuum leaks which could cause tissue in tissueacquisition chamber 142 to shift or move during treatment or cause suchtissue to lose contact with bio-barrier 152 and/or tissue interfacesurface 200 or to lose functional contact with applicator tissuetreatment surface 502 and/or cooling plate 128. Further, any movement oftissue interface module 116 with respect to applicator 114 duringtreatment may cause bubbles, voids or deformities to form betweenbio-barrier 152 and applicator tissue treatment surface 502. Engagementsurface 125 may further be arranged to be parallel to or substantiallyparallel (within e.g., 10 degrees), for example, surfaces at a distalend of magnetic extenders 179 on applicator 114. Engagement surface 125may further be arranged such that engagement surfaces 125 contactsubstantially all (e.g., eighty percent or more) of a distal end surfaceof magnetic extenders 179 on applicator 114. Engagement surface 125 mayfurther be arranged to maximize the magnetic force exerted on attachmentmechanism 126 by magnet 186 when magnet 186 is arranged to exert forceon attachment mechanism 126 through magnetic extenders 179. Engagementsurface 125 may be positioned to extend from applicator engagementsurface 178A to applicator engagement surface 178B, thus closing the gapbetween applicator engagement surface 178A and applicator engagementsurface 178B and creating a closed magnetic circuit.

Bio-barrier 152 (which may also be referred to as a first bio-barrier, amembrane or first membrane) may be configured and/or made of a materialwhich is substantially impermeable to both liquids (e.g., bodily fluidssuch as blood or sweat) and may also be impermeable to gases (e.g.,air). In embodiments of the invention, substantially impermeable maymean that a barrier is, for example, permeable enough to permit somefluid and/or air to pass but not permeable enough to effect thefunctionality of the barrier or of tissue interface module 116. Inembodiments of the invention, substantially impermeable may mean that abarrier is, for example, permeable enough to permit some fluid and/orair to pass but not permeable enough to allow biological fluids, such asblood or sweat, to pass. In some embodiments, bio-barrier 152 may beconstructed of impermeable materials, such as, for example, polyurethanefilm and may have a thickness of, for example, 0.0005 inches or 0.00085inches. In some embodiments, bio-barrier 152 may have a thickness ofbetween approximately 0.00075 inches and 0.001 inches. Bio-barrier 152is further designed to be sufficiently flexible to conform to applicatortissue treatment surface 502 (which may also be referred to as a tissuesurface, treatment surface or distal surface of a cooling plate), whereapplicator tissue treatment surface 502 is located at a distal end ofapplicator 114 (see, for example, FIG. 15) without creating bubbles,voids or deformities. In some embodiments of the invention (see, forexample, FIG. 9), bio-barrier 152 and filter 154 (which may also bereferred to as a second bio-barrier, a permeable bio-barrier or asemi-permeable bio-barrier) may work together to comprise amultifunctional bio-barrier. In embodiments of the invention, filter 154may comprise a first filter and a second filter. In embodiments of theinvention, filter 154 may comprise a first filter and a second filterwherein the first and second filters are positioned on opposite sides ofbio-barrier 152. In embodiments of the invention a multifunctionbio-barrier, comprising, for example, a first impermeable membrane and asecond air-permeable membrane, may be used to balance vacuum pressure inan applicator chamber 118 with vacuum pressure in a tissue acquisitionchamber 142 when air is drawn, by, for example, the attachment of vacuumports to applicator chamber 118. In embodiments of the invention amultifunction bio-barrier, comprising, for example, a first impermeablemembrane and a second air-permeable membrane, may be used in a vacuumpathway between applicator chamber 118 and a tissue acquisition chamber142 such that establishing a vacuum in applicator chamber 118 pulls airfrom tissue acquisition chamber 142 through the multifunctionbio-barrier while preventing biological fluids from passing from tissueacquisition chamber 142 into applicator chamber 118, preventingcontamination of the distal end of the applicator 114.

Bio-barrier 152 may be designed to have specific microwave and thermalcharacteristics. For example, bio-barrier 152 may be designed to have aloss tangent (tan(δ)) of 0.1 or less, and more particularly, a losstangent of approximately 0.0004. In some embodiments, Bio-barrier 152may have a loss tangent (tan(δ)) of less than one. In one embodiment,bio-barrier 152 may be made from a material having a lost tangent of oneor less. In other embodiments, bio-barrier 152 may be designed to havean electrical conductivity suitable for use a in a microwave system,such as having an electrical conductivity (σ) of between 0.0 and 0.2siemens/meter. In one embodiment of the invention bio-barrier 152 may bedesigned to have an electrical conductivity which is less than or equalto the transmission frequency in hertz (e.g., 5.8 GHz) multiplied by thereal part of the permittivity of bio-barrier 152. Bio-barrier 152 mayalso be designed to have a thermal conductivity and be made from amaterial suitable for use in a microwave system, such as having athermal conductivity of at least approximately 0.1 watts per meterKelvin (0.1 W/mK), and desirably 0.1 to 0.6 W/mK, and most desirably0.25 to 0.45 W/mK. Furthermore, bio-barrier 152 may be designed to havea heat transfer coefficient which makes it suitable for efficientlyremoving heat from tissue adjacent to bio-barrier 152, such as having aheat transfer coefficient of approximately 7874 W/m²K. In someembodiments, these measurements may vary by, for example, up to plus orminus twenty percent.

In some embodiments, bio-barrier 152 may be designed to conform toapplicator tissue treatment surface 502, particularly when a vacuum isapplied to applicator chamber 118. In some embodiments, bio-barrier 152may be configured to deflect at least 0.010 inches with a vacuum of, forexample, approximately −20 inches of mercury applied to applicatorchamber 118 without tearing or deforming. In some embodiments, thesemeasurements may vary by, for example, up to plus or minus twentypercent. Bio-barrier 152 may be designed to deflect or stretch to coverapplicator tissue treatment surface 502 without forming bubbles, voidsor deformities as such bubbles, voids or deformities may perturbmicrowave energy passing through bio-barrier 152. Such perturbationsmay, in certain circumstances, result in potential hot spots adjacenttissue interface surface 200 and/or between bio-barrier 152 andapplicator tissue treatment surface 502 (see, for example, FIG. 15). Inembodiments of the invention a distal surface of tissue cooling plate128 forms at least a portion of applicator tissue treatment surface 502of applicator 114. Such bubbles, voids or deformities may providepockets of insulation (e.g., air) between the skin surface and coolingplate 128, preventing cooling plate 128 from properly cooling thesurface of the skin as energy is applied through bio-barrier 152.

When tissue interface module 116 is placed against tissue, such as, forexample, the skin, skirt 206 may engage the tissue and form a sealedenclosure, wherein the enclosure includes the tissue, tissue acquisitionchamber 142, skirt 206, and bio-barrier 152. With tissue interfacemodule 116 positioned on applicator 114, vacuum may then be applied bypulling air through vacuum inlets 174 (also referred to as vacuum portsor vacuum inlet openings) at a distal end of applicator 114 (see, forexample, FIG. 15) to pull tissue into tissue acquisition chamber 142 andup against tissue interface surface 200, which, in some embodiments, maycomprise a distal surface of bio-barrier 152. In the embodiment of FIG.5, tissue interface module 116 may include, for example, four vacuumnotches 214. However, in other embodiments, more or fewer vacuum notches214 may be included around bio-barrier 152. Increasing the number ofvacuum notches 214 and positioning the vacuum notches around a perimeterof bio-barrier 152 may improve vacuum performance in the tissueacquisition chamber 142 and provide vacuum redundancy in the event thatone or more of vacuum notches 214 becomes clogged with blood, tissue, orother bodily fluids during treatment.

In some embodiments, filters 154 may be made from hydrophobic material.In other embodiments, filters 154 may have a pore size which allows forpassage of gas or air with a hydrophobicity that prevents the passage ofliquids such as blood and sweat. In some embodiments, filters 154 mayhave a physical size and be made from a material having a pore size suchthat the overall opening facilitates the equalization of pressure acrosssuch filter 154 within approximately 0.25 seconds (with a range ofbetween approximately 0.1 and 3 seconds) as tissue is drawn into tissueacquisition chamber 142. In some embodiments, filters 154 may have aphysical size and be made from a material having a pore size whichrestricts the flow of air sufficiently to create a pressure differentialbetween the air pressure in applicator chamber 118 and the air pressurein tissue acquisition chamber 142 during the time when air is flowingthrough filter 154. In some embodiments of the invention, filters 154may act as air restrictors, restricting, but not eliminating the freeflow of air between applicator chamber 118 and tissue acquisitionchamber 142. In some embodiments, filters 154 may be positioned suchthat air pressure in tissue acquisition chamber 142 is greater than airpressure in applicator chamber 118 during periods when air is beingdrawn from tissue acquisition chamber 142 through applicator chamber118, facilitating the positioning of a bio-barrier 152 againstapplicator tissue treatment surface 502 of applicator 114. In someembodiments, filters 154 may be positioned such that a vacuum in tissueacquisition chamber 142 is less than a vacuum in applicator chamber 118during periods when air is drawn from tissue acquisition chamber 142 andapplicator chamber 118, facilitating the positioning of a bio-barrier152 against applicator tissue treatment surface 502 of applicator 114.In other embodiments, filters 154 may have a flow rate of apredetermined value when vacuum is applied. In one embodiment, filters154 may have pore sizes of approximately 0.45 um and a flow area ofapproximately 1.86 square inches. In some embodiments, thesemeasurements may vary by, for example, up to plus or minus twentypercent. Filter 154 may be, for example, PTFE on a polyester backing,polyethylene film, nylon or other material meeting the criteria setforth above.

The embodiments of the tissue interface modules illustrated in FIGS. 23to 32 may include many of the features described herein with respect toprior described embodiments, including tissue interface module 116,applicator 114, vacuum channels 138, tissue acquisition chamber 142,filters 154, applicator chamber 118, electrical contacts 160, printedcircuit board 162, attachment mechanism 126, engagement surfaces 125,gasket 158, gasket engagement surface 500, inner insert 192, outer shell193, reflector 166, fluid trap 156, skirt 206, acquisition chamberopening 143 and vacuum interface 504 but omit the flexible bio-barrier152 shown in earlier embodiments. Embodiments of tissue interfacemodules illustrated in FIGS. 23 through 32 may further include anintermediate gasket 600 (which may also be referred to as anintermediate sealing member) and one or more air passages 602 extendingbetween tissue acquisition chamber 142 and fluid trap 156. Embodimentsof applicators illustrated in FIGS. 23 to 32 may include many of thefeatures described herein with respect to prior described embodiments,including cooling plate 128, applicator vacuum inlets 174, coolantconduits 185, tissue interface surface 200, magnetic extenders 179,magnet 186, sealing surface 121 and vacuum conduits 184. Tissueinterface surface 200 may, in some embodiments of the invention compriseat least a portion of applicator tissue treatment surface 502.

In embodiments of the invention, such as, for example, the embodimentsillustrated in FIGS. 23 to 32, when tissue interface module 116 isattached to applicator 114, applicator vacuum inlets 174 are configuredto be positioned in applicator chamber 118 (see, e.g., FIGS. 28 and 32)and to evacuate air from applicator chamber 118 through, for example,vacuum interface 504, creating a vacuum in applicator chamber 118. Whenpositioned on applicator 114, embodiments of the tissue interfacemodules illustrated in FIGS. 23-32 provide a seal (see, for example,intermediate gasket 600) between tissue interface module 116 andapplicator 114, thereby separating applicator chamber 118 from tissueacquisition chamber 142. This seal prevents air from flowing directlyfrom tissue acquisition chamber 142 to applicator chamber 118,facilitating the flow of air through filter 154 and air passages 602along air flow path A in FIGS. 28 and 32 when a vacuum is applied toapplicator chamber 118, through, for example, vacuum interface 504. Inthese embodiments of the invention, air extracted from applicatorchamber 118 will flow along path B as illustrated in FIGS. 28 and 32.

As shown in FIG. 27, when the skirt 206 of tissue interface module 116is placed against a patient's skin surface, the vacuum created in tissueacquisition chamber 142 in response to movement of air along these flowpaths A and B will draw the patient's skin and underlying tissue(including epidermis 410, dermis 412, dermal-hypodermal interface 414,hypodermis 416 and muscle 418) into tissue acquisition chamber 142toward the applicator cooling plate 128. The flow restricting nature offilters 154 may, in some embodiments be used to ensure that the airpressure in tissue acquisition chamber 142 is higher than the airpressure in applicator chamber 118 until the patient's tissue ceasesmoving into tissue acquisition chamber 142, at which point the airpressures in the two chambers will equalize. In embodiments of thetissue interface module illustrated in, for example, FIGS. 23 through28, intermediate seal, in the form of, for example, intermediate gasket600 may be positioned such that, when attached to applicator 114 gasket600 forms an air tight or substantially air tight seal against a surfaceof cooling plate 128. In embodiments of the tissue interface module 116illustrated in, for example, FIGS. 29 through 32, intermediate seal, inthe form of, for example, intermediate gasket 600 may be positioned suchthat, when attached to applicator 114 gasket 600 is adapted to form anair tight or substantially air tight seal against an outer surface ofapplicator 114. In embodiments of the invention illustrated in, forexample FIGS. 29-32, air passages 602 may be positioned outside oftissue acquisition chamber 142 to reduce or eliminate the potential forair passages 602 to be blocked by tissue in tissue acquisition chamber142. Some embodiments, such as, for example, those in FIG. 29 may alsoinclude vacuum notches 214 to facilitate the flow of air from tissueacquisition chamber 142 around the distal end of applicator 114 (whentissue interface module 116 is positioned on applicator 114) and intoair passages 602.

In the embodiments of the invention illustrated in FIG. 23, engagementsurface 125 may form an Angle Y between engagement surface 125 and aplane passing through gasket 600. In the embodiments of the inventionillustrated in FIG. 29, engagement surface 125 may form an Angle Zbetween engagement surface 125 and a plane passing through gasket 600.In other embodiments of the invention, Angles Y and Z may be measuredbetween engagement surface 125 and a plane running through or parallelto the distal surface of cooling plate 128 when tissue interface module116 is positioned on applicator 114. In embodiments of the invention,Angles Y and Z may be approximately 22.5 degrees. In embodiments of theinvention, Angles Y and Z may be between approximately 17.5 degrees and27.5 degrees, or alternatively, between approximately 12.5 degrees and32.5 degrees. In other embodiments, Angles Y and Z may vary, up to andincluding 45 degrees or more, depending upon the angle chosen for themating engagement surfaces on applicator 114.

In the embodiments of the invention illustrated in FIGS. 23 through 32,air flows through tissue interface module 116 when a vacuum is appliedto vacuum interface 504 at the proximal end of the tissue interfacemodule 116. With tissue interface module 116 positioned on applicator114 and tissue engaged, as, for example, in FIG. 27, air trapped intissue acquisition chamber 142 may flow, through the air passage A,including air passages 602, fluid trap 156, through filter 154 andvacuum channels 138, under attachment mechanism 126, through applicatorchamber 118 to vacuum interface 504 and into vacuum inlet 174 inapplicator 114. In embodiments of the invention, such as, for example,the embodiments illustrated in FIGS. 23-32, air may be prevented frombypassing filter 152 by the intermediate sealing member 600. Inembodiments of the invention, such as, for example, the embodimentsillustrated in FIGS. 1-22, air may be prevented from bypassing filter152 by bio-barrier 152. Air in applicator chamber 118 flows along path Bthrough vacuum interface 504 and into vacuum inlet 174.

Air flows through the interface module when a vacuum is applied to thevacuum interface at the proximal end of the tissue interface module.With the tissue interface module positioned on the applicator and notissue engaged, air entering the tissue acquisition chamber flows intothe tissue chamber, through the expandable aperture, into the vacuumtrap, through the filter, under the engagement plate, through theapplicator chamber to the vacuum interface and into the applicator. Withthe tissue interface module positioned on the applicator, and no tissueengaged, air in the applicator chamber flows through the applicatorchamber to the vacuum interface and into the applicator.

With the distal end of the tissue interface module positioned againsttissue, sealing the end of the tissue chamber from outside air, air inthe tissue acquisition chamber is evacuated from the tissue acquisitionchamber by flowing through the expandable channel, into the vacuum trap,through the filter, under the engagement plate, through the applicatorchamber to the vacuum interface and into the applicator, creating avacuum in the tissue acquisition chamber. The vacuum created in thetissue acquisition chamber pulls tissue into the tissue acquisitionchamber, filling the tissue acquisition chamber. With the tissueinterface module positioned on the applicator and tissue engaged, air inthe applicator chamber flows through the applicator chamber to thevacuum interface and into the applicator, creating a vacuum in theapplicator chamber.

With tissue engaged at the distal end of the tissue interface module,air evacuated from the tissue acquisition chamber must pass through afirst vacuum path which includes the tissue acquisition chamber, theexpandable aperture, the vacuum trap, the filter, a space under theengagement plate, the applicator chamber and the vacuum interface. Withtissue engaged at the distal end of the tissue interface module, airevacuated from the applicator chamber must pass through a second vacuumpath which includes the applicator chamber and the vacuum interface.

Air passing through the vacuum interface travels two pathways. Air inthe applicator chamber flows through a first, direct pathway from theapplicator chamber to the vacuum interface. Air in the tissueacquisition chamber travels a second, indirect, pathway which passesthrough the filter. The second, indirect pathway may further include oneor more of: an expandable aperture; a vacuum trap, an applicator chamberand a vacuum interface.

The engagement and proper positioning of tissue is facilitated bypositioning tissue at a distal end of a tissue acquisition chamber,forming a seal, pulling air from the tissue chamber though a pathwaywhich includes in some embodiments a multifunction bio-barrier, thebio-barrier being composed of at least two parts. The first part of thebio-barrier may be substantially impermeable to air and fluids. Thesecond part of the bio-barrier may be permeable to air but substantiallyimpermeable to fluids. The first part of the multifunction bio-barriermay be a flexible bio-barrier which performs one or more of thefollowing functions: preventing air from passing from the tissueacquisition chamber into the applicator chamber; preventing fluids frompassing from the tissue acquisition chamber into the applicator chamber;diverting air being removed from the tissue chamber into a path whichincludes the second part of the multifunction bio-barrier; forming asubstantially deformity free (e.g., no bubbles, voids or otherdeformities) seal against the distal end (e.g., cooling plate) of theapplicator; forming at least one wall of an expandable aperture betweenthe tissue acquisition chamber and the applicator chamber; and providinga pathway for energy and cooling to pass into tissue engaged in thetissue acquisition chamber. The second part of the multi-functionbio-barrier may be one or more hydrophobic filters which performs one ormore of the following functions: providing a pathway for air leaving thetissue acquisition chamber to enter the applicator chamber; preventingfluids (e.g., bodily fluids or lubricants) from passing from the tissueacquisition chamber into the applicator chamber; restricting the flow ofair between the tissue acquisition chamber and the applicator chamber;ensuring that, at least while air is flowing from the tissue acquisitionchamber to the applicator chamber, the air pressure in the tissueacquisition chamber is lower than the air pressure in the applicatorchamber.

With tissue engaged at the distal end of the tissue interface module,air will flow through the first and second vacuum paths until tissuefills the tissue acquisition chamber. Airflow through the second vacuumpath is restricted by the presence of the filter, resulting in a drop inair pressure across the filter such that the air pressure in the tissueacquisition chamber is lower than the air pressure in the applicatorchamber. The presence of the filter ensures that this imbalance ismaintained even in the presence of small air leaks in the seal betweenthe applicator and the tissue interface module.

In embodiments employing a flexible bio-barrier, the presence of avacuum imbalance with a higher pressure in the tissue acquisitionchamber than in the applicator chamber forces the flexible bio-barrieragainst the distal end of the applicator and maintains the position ofthe flexible bio-barrier against the distal end of the applicator astissue is drawn into the tissue acquisition chamber. The vacuumimbalance further assures that the flexible bio-barrier will sit againstthe distal end of the applicator without bubbles etc. until tissue fillsthe tissue acquisition chamber. Once the tissue acquisition chamber isfilled, the presence of the tissue maintains the bio-barrier against thedistal end of the applicator.

In embodiments employing a flexible bio-barrier, establishing andmaintaining a substantially discontinuity-free (e.g., bubble-free)interface between the flexible bio-barrier and the distal end of theapplicator is important for a number of reasons. It reduces the chancesof a burn resulting from an air pocket. It enhances the transfer of coldenergy from the cooling plate to the tissue. It eliminates theinsulating effect of air trapped between the flexible bio-barrier andthe cooling plate. It enhances the coupling of microwave energy from theapplicator to the tissue. It reduces or eliminates discontinuities whichmight perturb the microwaves being radiated into the skin.

In embodiments employing a flexible bio-barrier, the presence of avacuum imbalance with a higher pressure in the tissue acquisitionchamber than in the applicator chamber pulls the flexible bio-barrieragainst the distal end of the applicator, opening the expandableaperture and increasing the cross section of the vacuum path at theexpandable aperture. Opening the expandable aperture increases the sizeof the opening connecting the tissue acquisition chamber to the vacuumtrap. Opening the expandable aperture increases the cross sectional areaof the narrowest point in the airflow pathway between the tissueacquisition chamber and the vacuum trap. Opening the expandable apertureincreases the cross sectional area of the narrowest point in the airflowpathway between the tissue acquisition chamber and the applicatorchamber. Opening the expandable aperture facilitates the flow of airbetween the tissue acquisition chamber and the vacuum trap and reducesthe chances that airflow between the tissue acquisition chamber andvacuum trap would be blocked by, for example, tissue, bodily fluids orlubricants.

In embodiments employing a flexible bio-barrier, the tissue interfacemodule facilitates the efficient transfer of energy between theapplicator and the tissue by ensuring that the flexible bio-barrier ispulled against the distal end of the applicator in a manner whichminimizes discontinuities (e.g., bubbles) which could form between thedistal end of the applicator and the flexible bio-barrier. Theelimination of discontinuities is important because such discontinuitiescould: prevent the efficient cooling of the skin by insulating the skinunder the discontinuity from the cooling plate; result in the creationof “hot spots” which might cause patient burns; change the “load”characteristics of the skin/cooling plate interface at the frequency ofinterest, thus reducing the efficiency of energy transfer and,potentially, the effectiveness of the treatment.

Energy is transmitted to tissue through a method which includes a seriesof steps. The series of steps may include one or more of the following:positioning a tissue interface module at a distal end of an applicator;attaching the tissue interface module to the applicator by closing amagnetic circuit, channeling magnetic flux through an engagementmechanism on the tissue interface module; positioning the tissueinterface module so that the distal end of the tissue interface moduleis in contact with tissue such as, for example, skin; evacuating airfrom an applicator chamber at a proximal end of the tissue interfacemodule; evacuating air from a tissue acquisition chamber through theapplicator chamber; creating a pressure differential such that the airpressure in the applicator chamber is, during the tissue acquisitionperiod (the period during which tissue is being pulled into theacquisition chamber), lower than the air pressure in the tissueacquisition chamber; pulling air through a filter as the air passes fromthe tissue acquisition chamber into the applicator chamber; pulling aflexible bio-barrier against a distal side of a cooling plate positionedat the distal end of the applicator; forming a substantially defect-,bubble- and void-free interface between the flexible bio-barrier and thedistal end of the applicator; opening an expandable aperture positionedbetween the tissue acquisition chamber and the applicator chamber;pulling tissue into the tissue acquisition chamber by continuing toevacuate air from the applicator chamber.

Energy is transmitted through an applicator and a tissue interfacemodule. The energy transmission path in the applicator may include: anantenna; at least one field spreader; a fluid channel; and a coolingplate. The energy transmission path in the tissue interface module mayinclude: a vacuum interface, an applicator chamber; a flexiblebio-barrier and a tissue acquisition chamber. In this embodiment, theenergy is radiated through the center of the vacuum interface.

Applicator engages by placing engagement plates positioned in theapplicator chamber against parallel surfaces at the end of magneticextenders on the applicator such that magnetic the engagement platesclose a magnetic circuit which includes a magnet, two magnetic extendersand the engagement plates. The engagement plates are positioned at anangle of 22.5 degrees to ensure that they will be parallel to andcontact the ends of the magnetic extenders, creating the closed magneticcircuit. With the tissue interface module properly positioned and theengagement plates closing the magnetic circuit, the magnet may bepositioned to enable magnetic flux to flow through the closed magneticcircuit exerting a magnetic force which holds the tissue interfacemodule in place.

To facilitate the proper positioning of the tissue interface moduleprior to full engagement, the magnet may be positioned to generate afirst magnetic force until the tissue interface module is properlyseated, at which time, the magnet is moved in a manner which results inthe application of a second magnetic force, wherein the second magneticforce is greater than the first magnetic force.

To facilitate the proper placement of the tissue interface module priorto full engagement, the flux density in the magnetic circuit may be setat a first level until the tissue interface module is properlypositioned and may be increased once the tissue interface module isproperly positioned.

Removal of the tissue interface module may be accomplished by reducingthe magnetic force exerted on the tissue interface module. Removal ofthe tissue interface module may be accomplished by reducing the magneticflux density through the magnetic circuit formed when the tissueinterface module is attached to the applicator.

Air may be evacuated from the applicator chamber when the applicatorand/or system detects the presence of a tissue interface module. Avacuum may be used to initially position and hold the tissue interfacemodule prior to activation of the magnetic circuit.

One aspect of the invention provides a tissue interface module for usewith an applicator in a microwave-based tissue modification system. Thetissue interface module has an applicator chamber on a proximal side ofthe tissue interface module and a tissue acquisition chamber on a distalside of the tissue interface module. The applicator chamber may include:an opening adapted to receive the applicator; an attachment mechanismpositioned in the applicator chamber and adapted to attach the tissueinterface module to the applicator; a sealing member positioned at aproximal side of the applicator chamber; and a vacuum interfacepositioned at a proximal side of the applicator chamber and adapted toreceive a vacuum inlet positioned on a distal end of the applicator. Thetissue acquisition chamber may include a tissue acquisition opening on adistal side of the tissue interface module. The system may also includea flexible bio-barrier positioned between, and in fluid communicationwith, the applicator chamber and the tissue acquisition chamber, theflexible bio-barrier being substantially impermeable to air or fluids;an airflow pathway within the tissue interface module, the airflowpathway connecting the applicator chamber and the tissue acquisitionchamber; and a filter disposed in the airflow pathway connecting theapplicator chamber and the tissue acquisition chamber, the filter beingpermeable to air and substantially impermeable to fluids.

In some embodiments, the tissue interface module may also include avariable flow restrictor between, and in communication with, the tissueacquisition chamber and the filter. The variable flow restrictor may bepositioned in the airflow pathway. The variable flow restrictor may be aflexible element adapted to expand a flow opening in the airflow pathwayin response to a pressure difference between the tissue acquisitionchamber and the filter.

In some embodiments, the sealing member forms at least a portion of thevacuum interface and is adapted to provide a substantially air tightseal against a sealing surface on the applicator when the tissueinterface module is attached to the applicator with the attachmentmechanism.

Another aspect of the invention provides a tissue interface module foruse with an applicator in a microwave-based tissue modification system.The tissue interface module has an applicator chamber on a proximal sideof the tissue interface module and a tissue acquisition chamber on adistal side of the tissue interface module. The applicator chamber mayinclude: an opening adapted to receive an applicator; at least oneattachment plate positioned in the applicator chamber, the attachmentplate adapted to magnetically attach to elements of a magnetic circuitpositioned on a distal end of the applicator; a sealing memberpositioned at a proximal side of the applicator chamber; a vacuuminterface positioned at a proximal side of the applicator chamber andadapted to connect to a vacuum source. The tissue acquisition chambermay include a tissue acquisition opening on a distal side of the tissueinterface module. The tissue interface module may also have a flexiblebio-barrier positioned between, and in fluid communication with, theapplicator chamber and the tissue acquisition chamber, the flexiblebio-barrier being substantially impermeable to air or fluids; an airflowpathway within the tissue interface module, the airflow pathwayconnecting the applicator chamber and the tissue acquisition chamber;and a filter disposed in the airflow pathway connecting the applicatorchamber and the tissue acquisition chamber, the filter being permeableto air and substantially impermeable to fluids.

In some embodiments, the attachment plate has a magnetic element adaptedto form a magnetic circuit with magnetic elements in the applicator. Theattachment plate may be, e.g., a ferromagnetic plate.

In some embodiments, the tissue interface module has a tissue interfacemodule engagement surface adapted to engage with a correspondingapplicator engagement surface on the applicator, the tissue interfacemodule engagement surface being disposed at an angle of approximately17.5 degrees to 27.5 degrees, such as approximately 22.5 degrees, withrespect to the flexible bio-barrier. In some such embodiments, theattachment mechanism includes a ferromagnetic plate and the tissueinterface module engagement surface includes a surface of theferromagnetic plate.

Yet another aspect of the invention provides a tissue interface modulefor use with an applicator in a microwave-based tissue modificationsystem. The tissue interface module has an applicator chamber on aproximal side of the tissue interface module and a tissue acquisitionchamber on a distal side of the tissue interface module. The applicatorchamber may include: an opening adapted to receive an applicator; anattachment mechanism positioned in the applicator chamber and adapted toattach the tissue interface module to the applicator; a sealing memberpositioned at a proximal side of the applicator chamber; and a vacuuminterface positioned at the proximal side of the applicator chamber andadapted to connect to a vacuum source. The tissue acquisition chambermay have a tissue acquisition opening on a distal side of the tissueinterface module. The tissue interface module may also have a flexiblebio-barrier positioned between, and in fluid communication with, theapplicator chamber and the tissue acquisition chamber, the flexiblebio-barrier being substantially impermeable to air or fluids and mayalso be substantially transparent to microwave energy; a vacuum pathwaywithin the tissue interface module, the vacuum pathway including an exitopening at a proximal end of the tissue acquisition chamber; and afilter disposed between the exit opening and the vacuum interface, thefilter being permeable to air and substantially impermeable to fluids.

In some embodiments, the vacuum pathway extends from the distal end ofthe tissue acquisition chamber to the vacuum interface. The tissueinterface module may also include a second filter disposed between, andcommunicating with, the applicator chamber and the tissue acquisitionchamber, the second filter being permeable to air and substantiallyimpermeable to fluids. In some such embodiments, the filter and thesecond filter are positioned on opposing sides of the bio-barrier. Thefunctional surface area of the bio-barrier may also be approximately thesame as the functional surface area of the filter and the second filtercombined.

Still another aspect of the invention provides a tissue interface modulehaving an applicator chamber on a proximal side and a tissue acquisitionchamber on a distal side; a bio-barrier positioned between, and in fluidcommunication with, the applicator chamber and the tissue acquisitionchamber, the bio-barrier being substantially impermeable, flexible, andmicrowave transparent; a vacuum path extending from a distal end of thetissue acquisition chamber to a proximal end of the applicator chamberand including a filter, a vacuum trap and an expandable aperture; thevacuum path being adapted to facilitate the flow of air from the tissueacquisition chamber, through the expandable aperture, through the vacuumtrap, through the filter and into the applicator chamber when theapplicator chamber is attached to a vacuum source.

In some embodiments, the tissue interface module also includes: an outershell; an inner insert positioned in the outer shell to form a body ofthe tissue interface module; a gasket positioned on the inner insert and(i) providing a vacuum seal between the inner insert and the outer shellon a distal side of the gasket, (ii) being shaped to provide a vacuumseal to an applicator on a proximal side of the gasket, and (iii)forming a portion of the vacuum trap. The tissue interface module mayalso include a reflector (i) reflecting at least a portion of anymicrowave energy entering the applicator chamber; (ii) electricallyisolated from an applicator positioned in the applicator chamber; (iii)positioned between the outer shell and the inner insert; and (iv) havinga distal end surrounding at least a portion of the tissue acquisitionchamber.

In some embodiments, the tissue interface module also has a latch platepositioned in the applicator chamber on the inner insert and includingan attachment surface forming a predetermined angle with the bio-barrierwhen the bio-barrier is in a first position. The predetermined angle maybe between 17.5 degrees and 27.5 degrees, such as approximately 22.5degrees.

Yet another aspect of the invention provides a method of treating apatient including the following steps: attaching a tissue interfacemodule to an applicator, wherein the distal end of the applicator ispositioned in an applicator chamber of the tissue interface module;placing a distal opening of a tissue acquisition chamber of the tissueinterface module against a tissue surface; pulling a portion of thepatient's skin into the tissue acquisition chamber by creating a vacuumin the tissue acquisition chamber, the vacuum being created by drawingair from the tissue acquisition chamber to a vacuum source in theapplicator through a vacuum path including the applicator chamber and afilter between the applicator chamber and the tissue acquisitionchamber; and applying microwave energy to tissue positioned in thetissue acquisition chamber.

In some embodiments, the method also includes the step of cooling tissuein the tissue acquisition chamber during the application of microwaveenergy. In some embodiments, air is pulled from the tissue acquisitionchamber, through the filter, into the applicator chamber and into avacuum interface positioned on the distal end of the applicator.

In some embodiments, the applicator chamber and the tissue acquisitionchamber are separated by, and in fluid communication with, a flexiblebio-barrier. In such embodiments, the step of applying microwave energycan include the step of applying such energy through the flexiblebio-barrier, and the step of pulling a portion of the patient's skininto the tissue acquisition chamber pulls the flexible bio-barrieragainst a distal end of the applicator.

In some embodiments, the method includes the step of varying a size ofan opening between the tissue acquisition chamber and the filter duringthe step of creating a vacuum, such as by pulling the flexiblebio-barrier against the distal end of the applicator.

Yet another aspect of the invention provides a method of treating apatient including the following steps: attaching a tissue interfacemodule to an applicator, wherein the distal end of the applicator ispositioned in an applicator chamber of the tissue interface module;placing a distal opening of a tissue acquisition chamber of the tissueinterface module against a tissue surface; pulling a portion of thepatient's skin into the tissue acquisition chamber by reducing the airpressure in the applicator chamber below the air pressure in the tissueacquisition chamber; and applying microwave energy to tissue positionedin the tissue acquisition chamber.

In some embodiments, the method also includes the step of drawing airfrom the tissue acquisition chamber to a vacuum source in the applicatorthrough a vacuum path including the applicator chamber and a filterbetween the applicator chamber and the tissue acquisition chamber. Insome such embodiments, air pressure in the applicator chamber ismaintained at a pressure below the air pressure in the tissueacquisition chamber for at least as long as air continues to passthrough the filter. Some embodiments also add the step of cooling tissueadjacent the bio-barrier during the application of microwave energy.

In some embodiments, the applicator chamber and the tissue acquisitionchamber are separated by, and in fluid communication with, a flexiblebio-barrier. In such embodiments, the step of applying microwave energymay include the step of applying such energy through the flexiblebio-barrier, and the step of pulling a portion of the patient's skininto the tissue acquisition chamber may pull the flexible bio-barrieragainst a distal end of the applicator. In some embodiments, the step ofreducing the air pressure in the applicator chamber includes the step ofdrawing air from the applicator chamber through a vacuum inlet at aproximal end of the applicator chamber via a vacuum interface at adistal end of the applicator.

Another aspect of the invention provides a method of treating a patientincluding the steps of: magnetically coupling a tissue interface moduleto an applicator, wherein the distal end of the applicator is positionedin an applicator chamber of the tissue interface module; placing adistal opening of a tissue acquisition chamber of the tissue interfacemodule against a tissue surface; pulling a portion of the patient's skininto the tissue acquisition chamber by creating a vacuum in the tissueacquisition chamber, the vacuum being created by drawing air from thetissue acquisition chamber to a vacuum source in the applicator througha vacuum path that includes the applicator chamber and a filter betweenthe applicator chamber and the tissue acquisition chamber; and applyingmicrowave energy to tissue positioned in the tissue acquisition chamber.

In some embodiments, the step of magnetically coupling includes thesteps of: sensing the presence of the tissue interface module in theproximity of the distal end of the applicator; evacuating air from theapplicator chamber to position the tissue interface module on theapplicator; and energizing a magnetic circuit to engage the tissueinterface module to the applicator.

In some embodiments, the tissue interface module may have at least oneengagement plate, and the applicator may include a magnetic circuit withat least two magnetic extenders arranged at a distal end of theapplicator. In such embodiments, the step of positioning the tissueinterface module may include the steps of placing the engagement platein the proximity of the magnetic extenders and activating a magneticcircuit.

In some embodiments, the step of placing the engagement plate in theproximity of the magnetic extenders includes the step of placing anengagement surface of the engagement plate in contact with the magneticextenders such that the engagement plate forms at least a portion of amagnetic circuit with the magnetic extenders. In some such embodiments,the step of activating the magnetic circuit includes the step ofincreasing the magnetic force applied to the engagement surface.

In some embodiments, a bio-barrier separates the applicator chamber fromthe tissue acquisition chamber, the tissue interface module engagementsurface being disposed at an angle of approximately 22.5 degrees withrespect to the flexible bio-barrier.

Yet another aspect of the invention provides a method of treating tissueof a patient, the method including the following steps: mating a tissueinterface module to an applicator to place the distal end of a microwaveantenna, a cooling plate, and a vacuum inlet within an applicatorchamber of the tissue interface module; actuating a magnet to complete amagnetic circuit between an attachment mechanism of the tissue interfacemodule and the applicator; placing a distal opening of a tissueacquisition chamber of the tissue interface module against a tissuesurface; drawing a vacuum from a vacuum source in the applicator throughthe applicator chamber, a filter between the applicator chamber and thetissue acquisition chamber; and applying microwave energy to thepatient's tissue.

Still another aspect of the invention provides a method of pulling airthrough a consumable medical device, the method including the steps of:creating a vacuum in an applicator chamber of said consumable medicaldevice, the applicator chamber being separated from a tissue acquisitionchamber by a bio-barrier, the bio-barrier being flexible and impermeableto bodily fluids and air; pulling air into the applicator chamber from avacuum trap through a filter, the filter being permeable to air butsubstantially impermeable to bodily fluids; pulling air into the vacuumtrap through an expandable aperture, wherein the expandable aperture (i)substantially surrounds the tissue acquisition chamber, (ii) is formedat least in part by the bio-barrier, (iii) opens upon the application ofvacuum to the applicator chamber, which pulls said bio-barrier into theapplicator chamber and against a cooling plate; creating a vacuum insaid tissue acquisition chamber; and pulling tissue positioned outsidesaid tissue acquisition chamber into said tissue acquisition chamberusing said vacuum created in said tissue acquisition chamber.

Another aspect of the invention provides a tissue interface module foruse with an applicator in a microwave-based tissue modification system.The tissue interface module may include an applicator chamber adapted toreceive the applicator; a vacuum interface adapted to connect theapplicator chamber with a vacuum source; a tissue acquisition chamberwith an opening adapted to be applied to a patient's tissue; an airflowpath between the tissue acquisition chamber and the vacuum interface;and a flow restrictor (such as, e.g., an air filter) disposed in theairflow path such that air pressure in the tissue acquisition chamber isgreater than air pressure in the applicator chamber when air is movingfrom the applicator chamber through the vacuum interface to a vacuumsource.

In some embodiments, the tissue interface module also includes aflexible bio-barrier positioned between, and in fluid communicationwith, the applicator chamber and the tissue acquisition chamber, withthe flexible bio-barrier being substantially impermeable to air orfluids. In some such embodiments, the tissue interface module may alsoinclude an expandable aperture disposed in the airflow path, theexpandable aperture formed at least in part by the flexible bio-barrier.The expandable aperture may be disposed in a portion of the airflow pathbetween the tissue acquisition chamber and the flow restrictor.

Yet another aspect of the invention provides a method of treating apatient including the following steps: placing a distal end of anapplicator into an applicator chamber of a tissue interface module;placing a distal opening of a tissue acquisition chamber of the tissueinterface module against a skin surface of the patient; applying vacuumfrom a vacuum source to the applicator chamber; applying vacuum to thetissue acquisition chamber from the applicator chamber through a flowrestrictor so that the air pressure in the tissue acquisition chamber ishigher than the air pressure in the applicator chamber while air isflowing out of the tissue interface module through the vacuum interface;and applying microwave energy from the applicator to the skin surface.

In some embodiments, the applicator chamber and the tissue acquisitionchamber are separated by, and in fluid communication with, a flexiblebio-barrier, and the method further includes the step of moving theflexible bio-barrier against a distal end of the applicator. Theflexible bio-barrier may also form part of an aperture between thetissue acquisition chamber and the applicator chamber, and the step ofmoving the flexible bio-barrier may include the step of expanding theaperture.

In some embodiments, the flow restrictor includes a filter disposed inan airflow path between the tissue acquisition chamber and theapplicator chamber. The method may also include the step of pulling aportion of the skin surface into the tissue acquisition chamber prior tothe step of applying microwave energy.

Still another aspect of the invention provides a method of treating apatient including the following steps: placing a distal end of anapplicator into an applicator chamber of a tissue interface module;placing a distal opening of a tissue acquisition chamber of the tissueinterface module against a skin surface of the patient; reducing airpressure in the applicator chamber at a first rate; reducing airpressure in the tissue acquisition chamber at a second rate slower thanthe first rate so that the air pressure in the tissue acquisitionchamber is higher than the air pressure in the applicator chamber; andapplying microwave energy from the applicator to the skin surface.

In some embodiments, the applicator chamber and the tissue acquisitionchamber are separated by, and in fluid communication with, a flexiblebio-barrier, and the method further includes the step of moving theflexible bio-barrier against a distal end of the applicator. Theflexible bio-barrier may also form part of an aperture between thetissue acquisition chamber and the applicator chamber, and the step ofmoving the flexible bio-barrier may include the step of expanding theaperture.

In some embodiments, the flow restrictor includes a filter disposed inan airflow path between the tissue acquisition chamber and theapplicator chamber. The method may also include the step of pulling aportion of the skin surface into the tissue acquisition chamber prior tothe step of applying microwave energy.

Another aspect of the invention provides a tissue interface module foruse with an applicator in a microwave-based tissue modification system,the tissue interface module having an applicator chamber on a proximalside of the tissue interface module, the applicator chamber having anopening adapted to receive the applicator; an attachment mechanismpositioned in the applicator chamber and adapted to attach the tissueinterface module to the applicator; a proximal sealing member positionedat a proximal side of the applicator chamber and adapted to provide afirst seal between the tissue interface module and the applicator whenthe tissue interface module is attached to the applicator; a vacuuminterface positioned at a proximal side of the applicator chamber; atissue acquisition chamber including a tissue acquisition opening on adistal side of the tissue interface module; a central opening betweenthe applicator chamber and the tissue acquisition chamber; anintermediate sealing member surrounding the central opening and adaptedto provide a second seal between the tissue interface module and theapplicator and to prevent fluid flow through the central opening; anairflow pathway within the tissue interface module, the airflow pathwayconnecting the applicator chamber and the tissue acquisition chamber,the airflow pathway bypassing the intermediate sealing member and thecentral opening; and a filter disposed in the airflow pathway, thefilter being permeable to air and substantially impermeable to fluids.

In some embodiments, the vacuum interface is adapted to receive a vacuuminlet positioned on a distal end of the applicator. The proximal sealingmember may optionally form at least a portion of the vacuum interface.

In some embodiments, the second seal includes a seal between the tissueinterface module and a cooling plate positioned at a distal end of theapplicator. The tissue interface module may also include a distalsealing member positioned at the tissue acquisition opening.

Yet another aspect of the invention provides a tissue interface modulefor use with an applicator in a microwave-based tissue modificationsystem. The tissue interface module may include: an applicator chamberon a proximal side of the tissue interface module, the applicatorchamber having an opening adapted to receive an applicator; at least oneattachment plate positioned in the applicator chamber, the attachmentplate positioned to engage with elements of a magnetic circuitpositioned on a distal end of the applicator; a proximal sealing memberpositioned at a proximal side of the applicator chamber and adapted toprovide a first seal between the tissue interface module and theapplicator when the tissue interface module is attached to theapplicator; a vacuum interface positioned at a proximal side of theapplicator chamber and adapted to connect to a vacuum source; a tissueacquisition chamber including a tissue acquisition opening on a distalside of the tissue interface module; a central opening between theapplicator chamber and the tissue acquisition chamber; an intermediatesealing member surrounding at least a portion of the central opening andadapted to provide a second seal between the tissue interface module andthe applicator and to prevent fluid flow through the central opening; anairflow pathway within the tissue interface module, the airflow pathwayconnecting the applicator chamber and the tissue acquisition chamber,the airflow pathway bypassing the intermediate sealing member and thecentral opening; and a filter disposed in the airflow pathway, thefilter being permeable to air and substantially impermeable to fluids.

In some embodiments, the attachment plate includes a magnetic element(such as, e.g., a ferromagnetic plate) adapted to form a magneticcircuit with magnetic elements in the applicator.

In some embodiments, the tissue interface module has a tissue interfacemodule engagement surface adapted to engage with a correspondingapplicator engagement surface on the applicator, the tissue interfacemodule engagement surface being disposed at an angle of approximately22.5 degrees with respect to a plane containing the intermediate sealingmember. In some such embodiments, the attachment plate mechanismincludes a ferromagnetic plate and the tissue interface moduleengagement surface includes a surface of the ferromagnetic plate.

In some embodiments, the tissue interface has a tissue interface moduleengagement surface adapted to engage with a corresponding applicatorengagement surface on the applicator, the tissue interface moduleengagement surface being disposed at an angle of between approximately17.5 degrees and approximately 27.5 degrees with respect to a planecontaining the intermediate sealing member.

Still another aspect of the invention provides a tissue interface modulefor use with an applicator in a microwave-based tissue modificationsystem, the tissue interface module including: an applicator chamber ona proximal side of the tissue interface module, the applicator chamberhaving an opening adapted to receive an applicator; an attachmentmechanism positioned in the applicator chamber and adapted to attach thetissue interface module to the applicator; a proximal sealing memberpositioned at a proximal side of the applicator chamber and adapted toprovide a first seal between the tissue interface module and theapplicator when the tissue interface module is attached to theapplicator; a vacuum interface positioned at a proximal side of theapplicator chamber; a tissue acquisition chamber on a distal side of thetissue interface module, the tissue acquisition chamber having a tissueacquisition opening on a distal side of the tissue interface module anda central opening between the applicator chamber and the tissueacquisition chamber; an intermediate sealing member surrounding at leasta portion of the central opening and adapted to provide a second sealbetween the tissue interface module and the applicator and to preventfluid flow through the central opening; a vacuum pathway within thetissue interface module, the vacuum pathway including a first opening ona first side of the intermediate sealing member, a second opening on asecond side of the intermediate sealing member; and a filter disposedbetween the first and second openings, the filter being permeable to airand substantially impermeable to fluids; wherein the vacuum pathwayextends through the filter from a first side of the intermediate sealingmember to a second side of the intermediate sealing member when fluidflow through the central opening is prevented. In some embodiments, withthe tissue interface module affixed to the applicator, the vacuum flowpath begins at the distal end of the tissue acquisition chamber andterminates at the vacuum interface.

Another aspect of the invention provides a tissue interface modulehaving: an applicator chamber positioned on a proximal side of saidtissue interface module; a tissue acquisition chamber positioned on adistal side of said tissue interface module; a central opening; anintermediate sealing member surrounding at least a portion of thecentral opening and adapted to provide a seal between the tissueinterface module and the applicator and to prevent fluid flow throughthe central opening; a vacuum path extending from a proximal side of theintermediate sealing member to a distal side of the intermediate sealingmember, the vacuum path including a filter and a vacuum trap; whereinthe vacuum path is adapted to facilitate the flow of air from the tissueacquisition chamber, through the vacuum trap, through the filter andinto the applicator chamber when the applicator chamber is attached tothe applicator vacuum port when fluid flow through the central openingis prevented.

Yet another aspect of the invention provides a method of treating apatient including the following steps: positioning a distal end of anapplicator in an applicator chamber of a tissue interface module;sealing a central opening between the applicator chamber and a tissueacquisition chamber of the tissue interface module against the distalend of the applicator; applying a vacuum to the applicator chamber;placing a distal opening of a tissue acquisition chamber of the tissueinterface module against a tissue surface; pulling a portion of thepatient's tissue into the tissue acquisition chamber by creating avacuum in the tissue acquisition chamber, the vacuum being created bydrawing air from the tissue acquisition chamber to a vacuum source inthe applicator through a vacuum path comprising the applicator chamberand a filter between the applicator chamber and the tissue acquisitionchamber; and applying microwave energy to tissue positioned in thetissue acquisition chamber.

In some embodiments, the method also includes the step of cooling thetissue in the acquisition chamber. The method may also include the stepof sealing the applicator chamber against the applicator at a vacuuminterface.

In some embodiments, the method includes the step of magneticallyattaching the tissue interface module to the applicator such as, e.g.,by forming a magnetic circuit between elements of the applicator and thetissue interface module.

Another aspect of the invention provides a tissue interface module foruse with an applicator in a microwave-based tissue modification system,the tissue interface module including: an attachment mechanism on aproximal side of the tissue interface module adapted to attach to anapplicator; an applicator chamber adapted to receive a microwaveantenna, a cooling element, and a vacuum port of the applicator, theapplicator chamber comprising a bio-barrier on a distal side; a tissueacquisition chamber having a tissue acquisition opening on a distal sideof the tissue interface module; and a filter disposed between, andcommunicating with, the applicator chamber and the tissue acquisitionchamber, the filter having openings configured to permit air to pass andto prevent liquid from passing.

In some embodiments, the tissue interface module also has a variableflow restrictor between, and in communication with, the tissueacquisition chamber and the filter. The variable flow restrictor mayhave a flexible element adapted to expand a flow opening between thetissue acquisition chamber and the filter in response to a pressuredifference between the tissue acquisition chamber and the filter.

In some embodiments, the attachment mechanism has a magnetic element(such as, e.g., a ferromagnetic plate) adapted to magnetically attach toa corresponding element in the applicator. The tissue interface modulemay also have a tissue interface module engagement surface adapted toengage with a corresponding applicator engagement surface on theapplicator, the tissue interface module engagement surface beingdisposed at an angle of approximately 12.5 degrees to 32.5 degrees, orapproximately 17.5 degrees to 27.5 degrees, or approximately 22.5degrees, with respect to the bio-barrier.

In some embodiments, the tissue interface module also has a vacuum flowpath from the tissue acquisition chamber, through the filter, into theapplicator chamber. In some embodiments, the tissue interface module hasa vacuum flow path from the tissue acquisition chamber, through thefilter, through the applicator chamber, into the vacuum port of theapplicator.

In some embodiments, the tissue interface module may also have a secondfilter disposed between, and communicating with, the applicator chamberand the tissue acquisition chamber, the second filter having openingsconfigured to permit air to pass and to prevent liquid from passing. Insome such embodiments, the filter and the second filter are positionedon opposing sides of the bio-barrier. The bio-barrier may haveapproximately the same surface area as the filter and the second filtercombined.

Another aspect of the invention provides a method of treating tissue ofa patient including the following steps: attaching a tissue interfacemodule to an applicator to place a microwave antenna, a cooling plate,and a vacuum port within an applicator chamber of the tissue interfacemodule; placing a distal opening of a tissue acquisition chamber of thetissue interface module against a tissue surface; drawing a vacuum froma vacuum source in the applicator through the applicator chamber, afilter between the applicator chamber and the tissue acquisitionchamber; and applying microwave energy to the patient's tissue.

Some embodiments add the step of varying a size of an opening betweenthe tissue acquisition chamber and the filter during the step of drawinga vacuum, such as by moving a flexible member to change the size of theopening. In some embodiments, the attaching step includes the step ofmagnetically coupling the tissue interface module to the applicator.

In some embodiments, the applicator chamber has a bio-barrier on adistal side, and the attaching step includes the step of engaging amagnetic tissue interface module engagement surface with a correspondingapplicator engagement surface on the applicator, the tissue interfacemodule engagement surface being disposed at an angle of approximately17.5 degrees to 27.5 degrees with respect to the bio-barrier.

Still another aspect of the invention provides a microwave-based tissuemodification system having: a microwave applicator with a microwaveantenna, a cooling element, and a vacuum port; and a tissue interfacemodule with: an attachment mechanism on a proximal side of the tissueinterface module adapted to attach to the microwave applicator; anapplicator chamber adapted to connect to the microwave antenna, thecooling element, and the vacuum port of the microwave applicator, theapplicator chamber having a bio-barrier on a distal side; a tissueacquisition chamber having a tissue acquisition opening on a distal sideof the tissue interface module; and a filter disposed between, andcommunicating with, the applicator chamber and the tissue acquisitionchamber, the filter having openings configured to permit air to pass andto prevent liquid from passing.

In some embodiments, the tissue modification system also has a variableflow restrictor between, and in communication with, the tissueacquisition chamber and the filter. In some embodiments, the attachmentmechanism includes a magnetic element adapted to magnetically attach toa corresponding element in the applicator. The tissue modificationsystem may also include a tissue interface module engagement surfaceadapted to engage with a corresponding applicator engagement surface onthe microwave applicator, the tissue interface module engagement surfacebeing disposed at an angle of approximately 17.5 degrees to 27.5 degreeswith respect to the bio-barrier.

In some embodiments, the tissue modification system has a vacuum flowpath from the tissue acquisition chamber, through the filter, throughthe applicator chamber, into the vacuum port of the microwaveapplicator. The tissue interface module may also have a second filterdisposed between, and communicating with, the applicator chamber and thetissue acquisition chamber, the second filter having openings configuredto permit air to pass and to prevent liquid from passing. In some suchembodiments, the filter and the second filter are positioned on opposingsides of the bio-barrier.

Yet another aspect of the invention provides a tissue interface modulefor use with an applicator in a microwave-based tissue modificationsystem, the tissue interface module having: an attachment mechanism on aproximal side of the tissue interface module adapted to attach to anapplicator, the attachment mechanism including an engagement surfacethat forms an angle of approximately 17.5 degrees to 27.5 degrees fromhorizontal; an applicator chamber adapted to connect to a microwaveantenna, a cooling element, and a vacuum port of the applicator, theapplicator chamber comprising a bio-barrier on a distal side, whereinthe bio-barrier is configured to prevent air and liquid from passing; atissue acquisition chamber having a tissue acquisition opening definedby a skirt on a distal side of the tissue interface module; and a filterdisposed between, and communicating with, the applicator chamber and thetissue acquisition chamber, the filter having openings configured topermit air to pass and to prevent liquid from passing.

In some embodiments, the tissue interface module has a vacuum flow pathfrom the tissue acquisition chamber, through the filter, through theapplicator chamber, into the vacuum port of the microwave applicator.The tissue interface module may also include a second filter disposedbetween, and communicating with, the applicator chamber and the tissueacquisition chamber, the second filter having openings configured topermit air to pass and to prevent liquid from passing. In some suchembodiments, the filter and the second filter are positioned on opposingsides of the bio-barrier. In some embodiments, the tissue interfacemodule also has a fluid trap disposed between the tissue acquisitionchamber and the filter, the fluid trap configured to capture tissue andliquid.

Another aspect of the invention provides a consumable medical devicehaving: an applicator chamber positioned on a proximal side of saidconsumable; a tissue chamber positioned on a distal side of saidconsumable medical device; a first bio-barrier positioned between theapplicator chamber and the tissue chamber, the first bio-barrier being:substantially impermeable, flexible and microwave transparent; a vacuumpath extending from a distal end of the applicator chamber to a proximalend of the tissue chamber and including a second bio-barrier, a vacuumtrap, and an expandable aperture, the vacuum path being adapted tofacilitate the flow of air from the tissue chamber, through theexpandable aperture, through the vacuum trap, through the secondbio-barrier and into the applicator chamber.

In some embodiments, the consumable also includes a shell; an insertpositioned in the shell to form a body of said consumable; a gasketpositioned on the insert, providing a vacuum seal between the insert andthe shell on a distal side of the gasket, being shaped to provide avacuum seal to an applicator on a proximal side of the gasket andforming a portion of the vacuum trap.

In some embodiments, the consumable also includes a reflector reflectingat least a portion of any microwave energy entering the applicatorchamber, the reflector being electrically isolated from an applicatorpositioned in said applicator chamber, being positioned between theshell and the insert, and having a distal end surrounding at least aportion of the tissue chamber.

In some embodiments, the consumable also has a latch plate positioned inthe applicator chamber on said insert, forming a predetermined anglewith the first bio-barrier when the first bio-barrier is in a firstposition.

Still another aspect of the invention provides a method of transmittingenergy to a patient for the purpose of reducing sweat, the methodincluding the steps of: transmitting the energy through an applicatorhaving: an antenna; a field spreader, a fluid channel, and a coolingplate; and transmitting the energy through a consumable having: anapplicator chamber; a flexible bio-barrier; and a tissue chamber.

Yet another aspect of the invention provides a consumable including aflexible bio-barrier and a cooling plate configured to cooperate to formexpandable channel connecting a tissue chamber to an applicator chamber,the consumable including a vacuum path wherein air from a the tissuechamber passes through: the expandable channel; a fluid trap; a secondbio-barrier; vacuum channels separating second bio-barrier from anattachment mechanism (such as, e.g., a magnetic plate); and anapplicator chamber.

Another aspect of the invention provides a multifunctional connectoradapted to connect an applicator to a microwave generator consolethrough a cable assembly, the connector having: a cooling fluidconnector; a cooling fluid return connector; a microwave connector;electronic connectors; and vacuum connectors.

As for additional details pertinent to the present invention, materialsand manufacturing techniques may be employed as within the level ofthose with skill in the relevant art. The same may hold true withrespect to method-based aspects of the invention in terms of additionalacts commonly or logically employed. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein. Likewise, reference to a singular item,includes the possibility that there are plural of the same itemspresent. More specifically, as used herein and in the appended claims,the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

1. (canceled)
 2. A device for treating a patient comprising: a tissueinterface module coupled to an applicator, wherein a distal end of theapplicator is positioned in an applicator chamber of the tissueinterface module, the tissue interface module further having a tissueacquisition chamber separated from the applicator chamber via a flexiblebio-barrier; a vacuum path extending from a distal end of the tissueacquisition chamber to a proximal end of the applicator chamber, thevacuum path being adapted to facilitate the flow of air from the tissueacquisition chamber to the applicator chamber when the applicatorchamber is attached to a vacuum source; wherein the vacuum path isadapted to facilitate creation of a vacuum in the tissue acquisitionchamber to thereby facilitate treatment of a patient.
 3. The device ofclaim 2, wherein the bio-barrier is positioned between, and in fluidcommunication with, the applicator chamber and the tissue acquisitionchamber and is substantially impermeable to air or fluids.
 4. The deviceof claim 2, wherein the bio-barrier is microwave transparent.
 5. Thedevice of claim 2, wherein the vacuum path further comprises a filter, avacuum trap and an expandable aperture.
 6. The device of claim 1,wherein the vacuum path is adapted to facilitate creation of the vacuumto facilitate pulling of a patient's skin into the tissue acquisitionchamber.
 7. The device of claim 1, wherein an attachment mechanism ispositioned in the applicator chamber and is adapted to attach the tissueinterface module to the applicator.
 8. The device of claim 7, furthercomprising a sealing member positioned at a proximal side of theapplicator chamber.
 9. The device of claim 1, wherein the vacuum pathfurther comprises a filter and a variable flow restrictor, the variableflow restrictor being positioned between, and in communication with, thetissue acquisition chamber and the filter.
 10. The device of claim 9,wherein the variable flow restrictor comprises a flexible elementadapted to expand a flow opening in the vacuum path in response to apressure difference between the tissue acquisition chamber and thefilter.
 11. The device of claim 7, wherein the attachment mechanismcomprises at least one attachment plate positioned in the applicatorchamber, the attachment plate adapted to magnetically attach to elementsof a magnetic circuit positioned on a distal end of the applicator. 12.The device of claim 11, wherein the attachment plate comprises amagnetic element adapted to form a magnetic circuit with magneticelements in the applicator.
 13. The device of claim 12, wherein theattachment plate comprises a ferromagnetic plate.
 14. A device fortreating a patient comprising: a tissue interface module coupled to anapplicator, wherein a distal end of the applicator is positioned in anapplicator chamber of the tissue interface module, the tissue interfacemodule further having a tissue acquisition chamber separated from theapplicator chamber via a flexible bio-barrier; a vacuum path extendingfrom a distal end of the tissue acquisition chamber to a proximal end ofthe applicator chamber, the vacuum path being adapted to facilitate theflow of air from the tissue acquisition chamber to the applicatorchamber when the applicator chamber is attached to a vacuum source; anda filter disposed in the vacuum path connecting the applicator chamberand the tissue acquisition chamber, the filter being permeable to airand substantially impermeable to liquids; wherein the vacuum path isadapted to facilitate creation of a vacuum in the tissue acquisitionchamber to thereby facilitate treatment of a patient.
 15. The device ofclaim 14, wherein the bio-barrier is positioned between, and in fluidcommunication with, the applicator chamber and the tissue acquisitionchamber and is substantially impermeable to air or fluids.
 16. Thedevice of claim 14, wherein the bio-barrier is microwave transparent.17. The device of claim 14, wherein the vacuum path further comprises avariable flow restrictor, the variable flow restrictor being positionedbetween, and in communication with, the tissue acquisition chamber andthe filter.
 18. The device of claim 17, wherein the variable flowrestrictor comprises a flexible element adapted to expand a flow openingin the vacuum path in response to a pressure difference between thetissue acquisition chamber and the filter.
 19. The device of claim 1,wherein the vacuum path is adapted to facilitate creation of the vacuumto facilitate pulling of a patient's skin into the tissue acquisitionchamber.